| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. |
12 |
| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. |
6 |
| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. |
3 |
| Verzenio (abemaciclib) [package insert]. FDA. |
Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. |
3 |
| Akeega (abiraterone acetate and niraparib) [package insert]. FDA. |
AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. |
4 |
| Krazati (adagrasib) [package insert]. FDA. |
KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). |
1 |
| Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA. |
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within six months of completing adjuvant therapy. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA. |
1 |
| Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA. |
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA. |
1 |
| Gilotrif (afatinib) [package insert]. FDA. |
GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test (1.1) Limitations of Use: Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations. |
1 |
| Alecensa (alectinib) [package insert]. FDA. |
ALECENSA is a kinase inhibitor indicated for the adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive) as detected by an FDA-approved test. |
1 |
| Alecensa (alectinib) [package insert]. FDA. |
ALECENSA is a kinase inhibitor indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. |
1 |
| Piqray (alpelisib) [package insert]. FDA. |
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. |
3 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. |
1 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. |
1 |
| Trisenox (arsenic trioxide) [package insert]. FDA. |
TRISENOX is an arsenical indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. |
2 |
| Trisenox (arsenic trioxide) [package insert]. FDA. |
TRISENOX is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. |
2 |
| Scemblix (asciminib) [package insert]. FDA. |
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). |
2 |
| Scemblix (asciminib) [package insert]. FDA. |
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. |
2 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. |
1 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. |
2 |
| Tecentriq (atezolizumab) [package insert]. FDA. |
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. |
2 |
| Ayvakit (avapritinib) [package insert]. FDA. |
AYVAKIT is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. |
1 |
| Mektovi (binimetinib) [package insert]. FDA. |
MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. |
2 |
| Mektovi (binimetinib) [package insert]. FDA. |
MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. |
1 |
| Blincyto (blinatumomab) [package insert]. FDA. |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. |
1 |
| Blincyto (blinatumomab) [package insert]. FDA. |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). |
1 |
| Blincyto (blinatumomab) [package insert]. FDA. |
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. |
1 |
| Bosulif (bosutinib) [package insert]. FDA. |
BOSULIF is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. |
1 |
| Bosulif (bosutinib) [package insert]. FDA. |
BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. |
1 |
| Adcetris (brentuximab vedotin) [package insert]. FDA. |
ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. |
1 |
| Adcetris (brentuximab vedotin) [package insert]. FDA. |
ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. |
1 |
| Alunbrig (brigatinib) [package insert]. FDA. |
ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
1 |
| Xeloda (capecitabine) [package insert]. FDA. |
XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. |
1 |
| Truqap (capivasertib) [package insert]. FDA. |
TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. |
21 |
| Tabrecta (capmatinib) [package insert]. FDA. |
TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. |
2 |
| Libtayo (cemiplimab) [package insert]. FDA. |
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic. |
1 |
| Libtayo (cemiplimab) [package insert]. FDA. |
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic. |
1 |
| Zykadia (ceritinib) [package insert]. FDA. |
ZYKADIA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. |
1 |
| Erbitux (cetuximab) [package insert]. FDA. |
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. |
1 |
| Cotellic (cobimetinib) [package insert]. FDA. |
COTELLIC is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. |
2 |
| Xalkori (crizotinib) [package insert]. FDA. |
XALKORI is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. |
2 |
| Xalkori (crizotinib) [package insert]. FDA. |
XALKORI is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. |
1 |
| Xalkori (crizotinib) [package insert]. FDA. |
XALKORI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. |
2 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. |
2 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Tafinlar (dabrafenib) [package insert]. FDA. |
TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Vizimpro (dacomitinib) [package insert]. FDA. |
VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. |
2 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. |
2 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. |
2 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. |
1 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. |
2 |
| Sprycel (dasatinib) [package insert]. FDA. |
SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. |
1 |
| Jemperli (dostarlimab) [package insert]. FDA. |
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H). |
2 |
| Jemperli (dostarlimab) [package insert]. FDA. |
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. |
1 |
| Jemperli (dostarlimab) [package insert]. FDA. |
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Imfinzi (durvalumab) [package insert]. FDA. |
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations. |
5 |
| Imfinzi (durvalumab) [package insert]. FDA. |
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). |
1 |
| Orserdu (elacestrant) [package insert]. FDA. |
ORSERDU is an estrogen receptor antagonist indicated for treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. |
1 |
| Idhifa (enasidenib) [package insert]. FDA. |
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. |
9 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
2 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| Rozlytrek (entrectinib) [package insert]. FDA. |
ROZLYTREK is a kinase inhibitor indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
1 |
| Rozlytrek (entrectinib) [package insert]. FDA. |
ROZLYTREK is a kinase inhibitor indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. |
3 |
| Balversa (erdafitinib) [package insert]. FDA. |
BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. |
5 |
| Tarceva (erlotinib) [package insert]. FDA. |
TARCEVA is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. TARCEVA is not recommended for use in combination with platinum-based chemotherapy. |
2 |
| Afinitor (everolimus) [package insert]. FDA. |
AFINITOR is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. |
3 |
| Faslodex (fulvestrant) [package insert]. FDA. |
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. |
6 |
| Lytgobi (futibatinib) [package insert]. FDA. |
LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Iressa (gefitinib) [package insert]. FDA. |
IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. |
2 |
| Mylotarg (gemtuzumab ozogamicin) [package insert]. FDA. |
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older. |
1 |
| Mylotarg (gemtuzumab ozogamicin) [package insert]. FDA. |
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older. |
1 |
| Xospata (gilteritinib) [package insert]. FDA. |
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. |
8 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. |
2 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. |
2 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. |
2 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown. |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). |
1 |
| Gleevec (imatinib) [package insert]. FDA. |
Gleevec is a kinase inhibitor indicated for the adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. |
1 |
| Truseltiq (infigratinib) [package insert]. FDA. |
TRUSELTIQ is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Besponsa (inotuzumab ozogamicin) [package insert]. FDA. |
BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. |
1 |
| Yervoy (ipilimumab) [package insert]. FDA. |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in combination with nivolumab. |
2 |
| Yervoy (ipilimumab) [package insert]. FDA. |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab. |
1 |
| Yervoy (ipilimumab) [package insert]. FDA. |
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. |
3 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. |
10 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory AML. |
5 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes. |
5 |
| Tibsovo (ivosidenib) [package insert]. FDA. |
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated. |
5 |
| Tykerb (lapatinib) [package insert]. FDA. |
TYKERB is a kinase inhibitor indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. |
1 |
| Tykerb (lapatinib) [package insert]. FDA. |
TYKERB is a kinase inhibitor indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. |
3 |
| Vitrakvi (larotrectinib) [package insert]. FDA. |
VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. |
3 |
| Revlimid (lenalidomide) [package insert]. FDA. |
REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. |
1 |
| Lorbrena (lorlatinib) [package insert]. FDA. |
LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. |
1 |
| Margenza (margetuximab-cmkb) [package insert]. FDA. |
MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. |
4 |
| Rydapt (midostaurin) [package insert]. FDA. |
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. |
10 |
| Exkivity (mobocertinib) [package insert]. FDA. |
EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Nerlynx (neratinib) [package insert]. FDA. |
NERLYNX is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy. |
1 |
| Nerlynx (neratinib) [package insert]. FDA. |
NERLYNX is a kinase inhibitor indicated in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. |
1 |
| Tasigna (nilotinib) [package insert]. FDA. |
Tasigna is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. |
2 |
| Tasigna (nilotinib) [package insert]. FDA. |
Tasigna is a kinase inhibitor indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. |
2 |
| Tasigna (nilotinib) [package insert]. FDA. |
Tasigna is a kinase inhibitor indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. |
2 |
| Zejula (niraparib) [package insert]. FDA. |
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA. |
6 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with resectable (tumors >=4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. |
3 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
12 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
15 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
12 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
2 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
2 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
2 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
28 |
| Lynparza (olaparib) [package insert]. FDA. |
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. |
8 |
| Rezlidhia (olutasidenib) [package insert]. FDA. |
REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. |
5 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
2 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
2 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
4 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. |
1 |
| Ibrance (palbociclib) [package insert]. FDA. |
IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. |
3 |
| Ibrance (palbociclib) [package insert]. FDA. |
IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression following endocrine therapy. |
3 |
| Vectibix (panitumumab) [package insert]. FDA. |
Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) in combination with FOLFOX for first-line treatment. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown. |
1 |
| Vectibix (panitumumab) [package insert]. FDA. |
Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) >=1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS >=1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS >=10) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. |
8 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. |
1 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test. |
2 |
| Keytruda (pembrolizumab) [package insert]. FDA. |
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >= 1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT), with or without cisplatin and then as a single agent. |
1 |
| Pemazyre (pemigatinib) [package insert]. FDA. |
PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
2 |
| Pemazyre (pemigatinib) [package insert]. FDA. |
PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. |
1 |
| Perjeta (pertuzumab) [package insert]. FDA. |
PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Perjeta (pertuzumab) [package insert]. FDA. |
PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. |
2 |
| Perjeta (pertuzumab) [package insert]. FDA. |
PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. |
9 |
| Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. |
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. |
2 |
| Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. |
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. |
9 |
| Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. |
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with docetaxel for treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Iclusig (ponatinib) [package insert]. FDA. |
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). |
1 |
| Iclusig (ponatinib) [package insert]. FDA. |
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. |
1 |
| Iclusig (ponatinib) [package insert]. FDA. |
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase). Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. |
1 |
| Gavreto (pralsetinib) [package insert]. FDA. |
GAVRETO is a kinase inhibitor indicated for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). |
1 |
| Gavreto (pralsetinib) [package insert]. FDA. |
GAVRETO is a kinase inhibitor indicated for treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Cyramza (ramucirumab) [package insert]. FDA. |
CYRAMZA is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. |
2 |
| Augtyro (repotrectinib) [package insert]. FDA. |
AUGTYRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). |
1 |
| Augtyro (repotrectinib) [package insert]. FDA. |
AUGTYRO is a kinase inhibitor indicated for the treatment of adult and pedatric patients 12 years of age and older with solid tumors that (i) have a neutrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbility, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
3 |
| Kisqali (ribociclib) [package insert]. FDA. |
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. |
6 |
| Kisqali (ribociclib) [package insert]. FDA. |
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. |
3 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with relapsed or refractory, low grade or follicular, CD20-positive B- cell NHL as a single agent. |
1 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. |
3 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. |
1 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. |
1 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy. |
3 |
| Rituxan (rituximab) [package insert]. FDA. |
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL). |
1 |
| Rubraca (rucaparib) [package insert]. FDA. |
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. |
12 |
| Rubraca (rucaparib) [package insert]. FDA. |
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
4 |
| Trodelvy (sacituzumab govitecan) [package insert]. FDA. |
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. |
1 |
| Trodelvy (sacituzumab govitecan) [package insert]. FDA. |
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. |
3 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. |
1 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. |
1 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). |
1 |
| Retevmo (selpercatinib) [package insert]. FDA. |
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Lumakras (sotorasib) [package insert]. FDA. |
LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Talzenna (talazoparib) [package insert]. FDA. |
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. |
2 |
| Talzenna (talazoparib) [package insert]. FDA. |
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). |
24 |
| Tazverik (tazemetostat) [package insert]. FDA. |
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
7 |
| Tepmetko (tepotinib) [package insert]. FDA. |
TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. |
2 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. |
1 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use: MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. |
1 |
| Mekinist (trametinib) [package insert]. FDA. |
MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Herceptin (trastuzumab) [package insert]. FDA. |
Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2 -overexpressing breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin. |
1 |
| Herceptin (trastuzumab) [package insert]. FDA. |
Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either (i) in the metastatic setting, or (ii) in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. |
1 |
| Enhertu (trastuzumab deruxtecan) [package insert]. FDA. |
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. |
1 |
| Imjudo (tremelimumab-actl) [package insert]. FDA. |
IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. |
5 |
| Tukysa (tucatinib) [package insert]. FDA. |
TUKYSA is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. |
1 |
| Tukysa (tucatinib) [package insert]. FDA. |
TUKYSA is a kinase inhibitor indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. |
1 |
| Zelboraf (vemurafenib) [package insert]. FDA. |
ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. |
1 |
| Zelboraf (vemurafenib) [package insert]. FDA. |
ZELBORAF is indicated for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation. |
2 |
| Tagrisso (osimertinib) [package insert]. FDA. |
TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. |
2 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. |
2 |
| Lazcluze (lazertinib) [package insert]. FDA. |
LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. |
2 |
| Rybrevant (amivantamab-vmjw) [package insert]. FDA. |
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. |
2 |
| Elahere (mirvetuximab soravtansine-gynx) [package insert]. FDA. |
ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. |
3 |
| Ojemda (tovorafenib) [package insert]. FDA. |
OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. |
4 |
| Imfinzi (durvalumab) [package insert]. FDA. |
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. |
4 |
| Krazati (adagrasib) [package insert]. FDA. |
KRAZATI is an inhibitor of the RAS GTPase family indicated in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials. |
1 |
| Voranigo (vorasidenib) [package insert]. FDA. |
VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection. |
20 |
| Kisqali (ribociclib) [package insert]. FDA. |
KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. |
6 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>= 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. |
1 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. |
3 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. |
2 |
| Itovebi (inavolisib) [package insert]. FDA. |
ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. |
3 |
| Vyloy (zolbetuximab) [package insert]. FDA. |
VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test. |
2 |
| Ziihera (zanidatamab-hrii) [package insert]. FDA. |
ZIHERA is a bispecific HER2-directed antibody indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
3 |
| Bizengri (zenocutuzumab-zbco) [package insert]. FDA. |
BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Bizengri (zenocutuzumab-zbco) [package insert]. FDA. |
BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Ensacove (ensartinib) [package insert]. FDA. |
ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. |
1 |
| Braftovi (encorafenib) [package insert]. FDA. |
BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. |
1 |
| Scemblix (asciminib) [package insert]. FDA. |
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). |
2 |
| Revuforj (revumenib) [package insert]. FDA. |
REVUFORJ is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older. |
4 |
| Afinitor (everolimus) [package insert]. FDA. |
AFINITOR is a kinase inhibitor indicated for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. |
2 |
| Afinitor (everolimus) [package insert]. FDA. |
AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. |
2 |
| Opdivo (nivolumab) [package insert]. FDA. |
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. |
2 |
| Ibtrozi (taletrectinib) [package insert]. FDA. |
IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). |
1 |
| Emrelis (telisotuzumab vedotin-tllv) [package insert]. FDA. |
EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [>=50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. |
1 |
| Avmapki Fakzynja co-pack (avutometinib potassium; defactinib hydrochloride) [package insert]. FDA. |
AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. |
2 |
| Datroway (datopotamab deruxtecan-dlnk) [package insert]. FDA. |
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. |
5 |
| Datroway (datopotamab deruxtecan-dlnk) [package insert]. FDA. |
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. |
3 |
| Zegfrovy (sunvozertinib) [package insert]. FDA. |
ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). |
1 |
| Hernexeos (zongertinib) [package insert]. FDA. |
HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
1 |
| Adcetris (brentuximab vedotin) [product monograph]. HC. |
ADCETRIS is indicated for the treatment of previously untreated adult patients with systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumours express CD30, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). |
3 |
| Adcetris (brentuximab vedotin) [product monograph]. HC. |
ADCETRIS is indicated for the treatment of adult patients with CD30-expressing MF who have received prio systemic therapy |
1 |
| Afinitor (everolimus) [product monograph]. HC. |
AFINITOR is indicated for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer in combination with exemestane after recurrence or progression following treatment with letrozole or anastrozole. |
3 |
| Akeega (abiraterone acetate and niraparib) [product monograph]. HC. |
AKEEGA (niraparib and abiraterone acetate) is indicated with prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom chemotherapy is not clinically indicated. |
0 |
| Alecensaro (alectinib) [product monograph]. HC. |
ALECENSARO (alectinib) is indicated for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
1 |
| Alunbrig (brigatinib) [product monograph]. HC. |
ALUNBRIG (brigatinib) is indicated as a monotherapy for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
1 |
| Augtyro (repotrectinib) [product monograph]. HC. |
AUGTYRO (repotrectinib capsules) is indicated for treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). |
1 |
| Balversa (erdafitinib) [product monograph]. HC. |
BALVERSA (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy. |
5 |
| Besponsa (inotuzumab ozogamicin) [product monograph]. HC. |
BESPONSA (inotuzumab ozogamicin for injection) is indicated for monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). |
1 |
| Blincyto (blinatumomab) [product monograph]. HC. |
BLINCYTO (blinatumomab for injection) is indicated for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. |
0 |
| Blincyto (blinatumomab) [product monograph]. HC. |
BLINCYTO (blinatumomab for injection) is indicated for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. |
0 |
| Blincyto (blinatumomab) [product monograph]. HC. |
BLINCYTO (blinatumomab for injection) is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. |
1 |
| Blincyto (blinatumomab) [product monograph]. HC. |
BLINCYTO (blinatumomab for injection) is indicated for the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL. |
0 |
| Bosulif (bosutinib) [product monograph]. HC. |
BOSULIF (bosutinib) is indicated for the treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). |
1 |
| Bosulif (bosutinib) [product monograph]. HC. |
BOSULIF (bosutinib) is indicated for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy. |
1 |
| Braftovi (encorafenib) [product monograph]. HC. |
BRAFTOVI (encorafenib) is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. |
1 |
| Braftovi (encorafenib) [product monograph]. HC. |
BRAFTOVI (encorafenib) is indicated, in combination with cetuximab, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test, after prior therapy. |
1 |
| Cotellic (cobimetinib) [product monograph]. HC. |
COTELLIC (cobimetinib) is indicated for use in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Enhertu (trastuzumab deruxtecan) [product monograph]. HC. |
ENHERTU (trastuzumab deruxtecan for injection) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy. |
2 |
| Enhertu (trastuzumab deruxtecan) [product monograph]. HC. |
ENHERTU (trastuzumab deruxtecan for injection) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received prior treatment with trastuzumab emtansine (T-DM1). |
1 |
| Enhertu (trastuzumab deruxtecan) [product monograph]. HC. |
ENHERTU (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. |
0 |
| Enhertu (trastuzumab deruxtecan) [product monograph]. HC. |
ENHERTU (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. |
1 |
| Erbitux (cetuximab) [product monograph]. HC. |
ERBITUX (cetuximab) is indicated for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC) in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment. |
1 |
| Erbitux (cetuximab) [product monograph]. HC. |
ERBITUX (cetuximab) is indicated for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC) in combination with irinotecan in patients who are refractory to other irinotecan-based chemotherapy regimens. |
1 |
| Erbitux (cetuximab) [product monograph]. HC. |
ERBITUX (cetuximab) is indicated as a single agent in patients who are intolerant to irinotecan-based chemotherapy for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC). |
1 |
| Erbitux (cetuximab) [product monograph]. HC. |
ERBITUX (cetuximab) is indicated as a single agent for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC) in patients who have failed both irinotecan- and oxaliplatin-based regimens and who have received a fluoropyrimidine. |
1 |
| Faslodex (fulvestrant) [product monograph]. HC. |
FASLODEX (fulvestrant) is indicated for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. |
1 |
| Giotrif (afatinib) [product monograph]. HC. |
GIOTRIF (afatinib) is indicated as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naïve patients with metastatic adenocarcinoma of the lung with activating EGFR mutation(s). |
2 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with newly diagnosed, Philadelphia chromosome-positive, chronic myeloid leukemia (CML) in chronic phase. |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in blast crisis or accelerated phase, or in chronic phase after failure of interferon-alpha therapy. |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for use as a single agent for induction phase therapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. |
4 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with aggressive sub-types of systemic mastocytosis (ASM and SMAHNMD) without the D816V c-Kit mutation. |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRα rearrangement. |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). |
1 |
| Gleevec (imatinib) [product monograph]. HC. |
GLEEVEC (imatinib mesylate) is indicated for the adjuvant treatment of adult patients who are at intermediate to high risk of relapse following complete resection of Kit (CD117) positive GIST. |
1 |
| Herceptin (trastuzumab) [product monograph]. HC. |
HERCEPTIN (trastuzumab for injection) is indicated for the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours overexpress HER2, following surgery and after chemotherapy. |
1 |
| Herceptin (trastuzumab) [product monograph]. HC. |
HERCEPTIN (trastuzumab for injection) is indicated for the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours overexpress HER2, following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. |
1 |
| Herceptin (trastuzumab) [product monograph]. HC. |
HERCEPTIN (trastuzumab for injection) is indicated for the treatment of patients with early stage breast cancer with ECOG 0-1 status, whose tumours overexpress HER2, in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. |
1 |
| Herceptin (trastuzumab) [product monograph]. HC. |
HERCEPTIN (trastuzumab for injection) is indicated for the treatment of patients with metastatic breast cancer (MBC) whose tumours overexpress HER2. |
1 |
| Herceptin (trastuzumab) [product monograph]. HC. |
HERCEPTIN (trastuzumab for injection) can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Herceptin (trastuzumab) [product monograph]. HC. |
HERCEPTIN (trastuzumab for injection) in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. |
0 |
| Ibrance (palbociclib) [product monograph]. HC. |
IBRANCE (palbociclib) is indicated for the treatment of pre/perimenopausal or postmenopausal women, or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. |
3 |
| Ibrance (palbociclib) [product monograph]. HC. |
IBRANCE (palbociclib) is indicated for the treatment of pre/perimenopausal or postmenopausal women, or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression after prior endocrine therapy. |
3 |
| Iclusig (ponatinib) [product monograph]. HC. |
ICLUSIG (ponatinib tablets) is indicated for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid leukemia (CML) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including CML that is T315I mutation positive or where there is prior TKI resistance or intolerance |
1 |
| Iclusig (ponatinib) [product monograph]. HC. |
ICLUSIG (ponatinib tablets) is indicated for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including Ph+ ALL that is T315I mutation positive or where there is prior TKI resistance or intolerance |
1 |
| Imfinzi (durvalumab) [product monograph]. HC. |
IMFINZI (durvalumab) in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. |
1 |
| Imfinzi (durvalumab) [product monograph]. HC. |
Imfinzi (durvalumab) in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR) endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Imfinzi as monotherapy. |
1 |
| Iressa (gefitinib) [product monograph]. HC. |
IRESSA (gefitinib) is indicated for the first line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR-TK |
3 |
| Itovebi (inavolisib) [product monograph]. HC. |
ITOVEBI (inavolisib film-coated tablets), in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment. |
3 |
| Jemperli (dostarlimab) [product monograph]. HC. |
JEMPERLI (dostarlimab for injection) is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum containing regimen. |
2 |
| Kadcyla (ado-trastuzumab emtansine) [product monograph]. HC. |
KADCYLA (trastuzumab emtansine for injection) monotherapy is indicated for the treatment of HER2-positive metastatic breast cancer patients who received both prior treatment with trastuzumab and a taxane, separately or in combination. |
1 |
| Kadcyla (ado-trastuzumab emtansine) [product monograph]. HC. |
KADCYLA monotherapy indicated for the adjuvant treatment of HER2-positive early breast cancer patients who have residual invasive disease following neoadjuvant taxane and trastuzumab-based treatment. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab) is indicated for the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor. |
2 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab) as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS) ≥ 1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC. |
0 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab) is indicated Keytruda as monotherapy is indicated for the treatment of adult patients with metastatic NSCLC whose tumours express PD-L1 (TPS ≥ 1%) as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab) is indicated, as monotherapy, for the treatment of adult patients with metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by a validated test. |
2 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab) is indicated as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. |
2 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation. |
0 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab) is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression (Combined Positive Score [CPS] ≥ 1) as determined by a validated test. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy,is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumours express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by a validated test. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test. |
1 |
| Keytruda (pembrolizumab) [product monograph]. HC. |
KEYTRUDA (pembrolizumab), in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test. |
4 |
| Kisqali (ribociclib) [product monograph]. HC. |
KISQALI (ribociclib tablets) is indicated, in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, or men ,with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. |
6 |
| Kisqali (ribociclib) [product monograph]. HC. |
KISQALI (ribociclib tablets) is indicated, in combination with fulvestrant for the treatment of postmenopausal women, with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. |
3 |
| Lazcluze (lazertinib) [product monograph]. HC. |
LAZCLUZE (lazertinib) in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. |
2 |
| Libtayo (cemiplimab) [product monograph]. HC. |
LIBTAYO (cemiplimab for injection) is indicated as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC. |
2 |
| Libtayo (cemiplimab) [product monograph]. HC. |
LIBTAYO (cemiplimab for injection) in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with NSCLC whose tumors have no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC. |
0 |
| Lorbrena (lorlatinib) [product monograph]. HC. |
LORBRENA (lorlatinib) is indicated as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
1 |
| Lorbrena (lorlatinib) [product monograph]. HC. |
LORBRENA (lorlatinib) is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or aectinib. |
1 |
| Lumakras (sotorasib) [product monograph]. HC. |
LUMAKRAS (sotorasib) is indicated for the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. |
1 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA (olaparib) is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before LYNPARZA treatment is initiated. |
2 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA (olaparib) is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2- negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated. |
2 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA (olaparib) is indicated as monotherapy for the maintenance treatment of adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Patients must have confirmation of BRCA mutation (identified by either germline or tumour testing) before LYNPARZA treatment is initiated. |
12 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA (olaparib) is indicated as an add-on maintenance treatment to bevacizumab of adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability. BRCA mutation status (germline or somatic) and/or genomic instability must be confirmed before LYNPARZA treatment is initiated. |
12 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA (olaparib) is indicated as monotherapy for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated. |
2 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA (olaparib) is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castrationresistant Prostate Cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent. BRCA or ATM mutations must be confirmed before LYNPARZA treatment is initiated. |
6 |
| Lynparza (olaparib) [product monograph]. HC. |
LYNPARZA is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before LYNPARZA treatment is initiated. |
8 |
| Mekinist (trametinib) [product monograph]. HC. |
MEKINIST (trametinib) is indicated, as a monotherapy or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
3 |
| Mekinist (trametinib) [product monograph]. HC. |
MEKINIST (trametinib), in combination with dabrafenib, is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph nodes, following complete resection. |
0 |
| Mekinist (trametinib) [product monograph]. HC. |
MEKINIST (trametinib) in combination with dabrafenib is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. |
1 |
| Mekinist (trametinib) [product monograph]. HC. |
MEKINIST (trametinib) in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Mekinist (trametinib) [product monograph]. HC. |
MEKINIST (trametinib) in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment. |
0 |
| Mektovi (binimetinib) [product monograph]. HC. |
MEKTOVI (binimetinib) is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. |
2 |
| Mylotarg (gemtuzumab ozogamicin) [product monograph]. HC. |
Mylotarg (gemtuzumab ozogamicin for injection) is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia. |
1 |
| Nerlynx (neratinib) [product monograph]. HC. |
NERLYNX (neratinib) is indicated for the extended adjuvant treatment of women with early-stage hormone receptor positive and HER2-overexpressed/amplified breast cancer, within one year after completion of trastuzumab-based adjuvant therapy. |
3 |
| Nerlynx (neratinib) [product monograph]. HC. |
NERLYNX (neratinib) is indicated in combination with capecitabine for the treatment of patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. |
1 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. |
2 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving OPDIVO. |
0 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab) in combination with ipilimumab, is indicated for the treatment of adult patients with metastatic NSCLC, expressing PD-L1 ≥ 1% as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC. |
1 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab), in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC. |
0 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab), in combination with ipilimumab, is indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan. |
0 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with HER2 negative advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. |
0 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab), in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression ≥ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC. |
1 |
| Opdivo (nivolumab) [product monograph]. HC. |
OPDIVO (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable or metastatic ESCC, with tumour cell PD-L1 expression ≥ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC. |
2 |
| Pemazyre (pemigatinib) [product monograph]. HC. |
PEMAZYRE (pemigatinib) is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. |
2 |
| Perjeta (pertuzumab) [product monograph]. HC. |
PERJETA (pertuzumab for injection) in combination with trastuzumab and chemotherapy is indicated for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer. |
13 |
| Perjeta (pertuzumab) [product monograph]. HC. |
PERJETA (pertuzumab) is indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Phesgo (pertuzumab and trastuzumab) [product monograph]. HC. |
PHESGO (pertuzumab and trastuzumab) in combination with chemotherapy is indicated for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer. |
13 |
| Phesgo (pertuzumab and trastuzumab) [product monograph]. HC. |
PHESGO (pertuzumab and trastuzumab) in combination with chemotherapy is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer with lymph node positive and/or hormone receptor negative disease. |
0 |
| Phesgo (pertuzumab and trastuzumab) [product monograph]. HC. |
PHESGO (pertuzumab and trastuzumab), is indicated in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC), who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. |
1 |
| Piqray (alpelisib) [product monograph]. HC. |
PIQRAY (alpelisib), in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen. |
0 |
| Retevmo (selpercatinib) [product monograph]. HC. |
RETEVMO (selpercatinib) is indicated as monotherapy for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adult patients. |
1 |
| Retevmo (selpercatinib) [product monograph]. HC. |
RETEVMO (selpercatinib) is indicated as monotherapy for the treatment of RET-mutant medullary thyroid cancer (MTC) in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease. |
1 |
| Retevmo (selpercatinib) [product monograph]. HC. |
RETEVMO (selpercatinib) is indicated as monotherapy for the treatment of RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib. |
1 |
| Revlimid (lenalidomide) [product monograph]. HC. |
REVLIMID (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on red blood cell transfusion independence response rates. Overall survival benefit has not been demonstrated. |
1 |
| Rituxan (rituximab) [product monograph]. HC. |
RITUXAN (rituximab for injection) is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma. |
2 |
| Rituxan (rituximab) [product monograph]. HC. |
RITUXAN (rituximab for injection) is indicated for the treatment of patients with CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy. |
2 |
| Rituxan (rituximab) [product monograph]. HC. |
RITUXAN (rituximab for injection) is indicated for the treatment of patients with previously untreated Stage III/IV follicular, CD20 positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. |
1 |
| Rozlytrek (entrectinib) [product monograph]. HC. |
ROZLYTREK (entrectinib) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options. |
3 |
| Rozlytrek (entrectinib) [product monograph]. HC. |
ROZLYTREK (entrectinib) is indicated for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) not previously treated with crizotinib. |
1 |
| Rybrevant (amivantamab-vmjw) [product monograph]. HC. |
RYBREVANT (amivantamab for injection) is indicated in combination with carboplatin and pemetrexed for the treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal-growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib. |
2 |
| Rybrevant (amivantamab-vmjw) [product monograph]. HC. |
RYBREVANT (amivantamab for injection) is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic NSCLC with activating EGFR Exon 20 insertion mutations. |
1 |
| Rybrevant (amivantamab-vmjw) [product monograph]. HC. |
RYBREVANT (amivantamab for injection) is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. |
1 |
| Rydapt (midostaurin) [product monograph]. HC. |
RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML). |
9 |
| Scemblix (asciminib) [product monograph]. HC. |
SCEMBLIX (asciminib tablets) is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors. |
0 |
| Sprycel (dasatinib) [product monograph]. HC. |
SPRYCEL (dasatinib) is indicated for the treatment of adults with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. |
0 |
| Sprycel (dasatinib) [product monograph]. HC. |
SPRYCEL (dasatinib) is indicated for the treatment of adults with Ph+ chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate. |
0 |
| Sprycel (dasatinib) [product monograph]. HC. |
SPRYCEL (dasatinib) is indicated for the treatment of adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. |
0 |
| Tabrecta (capmatinib) [product monograph]. HC. |
TABRECTA (capmatinib tablets) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. |
2 |
| Tafinlar (dabrafenib) [product monograph]. HC. |
TAFINLAR (dabrafenib mesylate) is indicated as a monotherapy, or in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
2 |
| Tafinlar (dabrafenib) [product monograph]. HC. |
TAFINLAR (dabrafenib mesylate), in combination with trametinib, is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection. |
0 |
| Tafinlar (dabrafenib) [product monograph]. HC. |
TAFINLAR (dabrafenib mesylate) in combination with trametinib is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. |
1 |
| Tafinlar (dabrafenib) [product monograph]. HC. |
TAFINLAR (dabrafenib mesylate) in combination with trametinib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. |
1 |
| Tafinlar (dabrafenib) [product monograph]. HC. |
TAFINLAR (dabrafenib mesylate) in combination with trametinib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment. |
1 |
| Tagrisso (osimertinib) [product monograph]. HC. |
TAGRISSO (osimertinib) is indicated as adjuvant therapy after tumour resection in patients with stage IB-IIIA1 non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. |
2 |
| Tagrisso (osimertinib) [product monograph]. HC. |
TAGRISSO (osimertinib) is indicated for the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. |
2 |
| Tagrisso (osimertinib) [product monograph]. HC. |
TAGRISSO (osimertinib) is indicated for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. |
2 |
| Tagrisso (osimertinib) [product monograph]. HC. |
TAGRISSO (osimertinib) is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. |
4 |
| Tagrisso (osimertinib) [product monograph]. HC. |
TAGRISSO (osimertinib) is indicated for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. |
1 |
| Talzenna (talazoparib) [product monograph]. HC. |
TALZENNA (talazoparib) is indicated as a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments. |
0 |
| Tasigna (nilotinib) [product monograph]. HC. |
TASIGNA (nilotinib) 150 mg and 200 mg capsules are indicated for The treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). |
0 |
| Tasigna (nilotinib) [product monograph]. HC. |
TASIGNA (nilotinib) 150mg and 200mg capsules are indicated for the treatment of pediatric patients 2 years of age and older with newly diagnosed Ph+ CML-CP. |
0 |
| Tasigna (nilotinib) [product monograph]. HC. |
TASIGNA (nilotinib) 150 mg and 200 mg capsules are indicated for the treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib. |
0 |
| Tasigna (nilotinib) [product monograph]. HC. |
TASIGNA (nilotinib) 150 mg and 200 mg capsules are indicated for the treatment of pediatric patients 2 years of age and older with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. |
0 |
| Tecentriq (atezolizumab) [product monograph]. HC. |
TECENTRIQ (atezolizumab, concentrate for solution for infusion) is indicated as monotherapy, as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with Stage II to IIIA* NSCLC whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TCs) |
1 |
| Tecentriq (atezolizumab) [product monograph]. HC. |
TECENTRIQ (atezolizumab, concentrate for solution for infusion) is indicated as monotherapy, for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering ≥ 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations. |
2 |
| Tecentriq (atezolizumab) [product monograph]. HC. |
TECENTRIQ (atezolizumab, concentrate for solution for infusion) is indicated in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic non-squamous NSCLC. |
0 |
| Tecentriq (atezolizumab) [product monograph]. HC. |
TECENTRIQ (atezolizumab, concentrate for solution for infusion) is indicated in combination with nab-paclitaxel and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous, non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations. |
0 |
| Tecentriq (atezolizumab) [product monograph]. HC. |
TECENTRIQ (atezolizumab, concentrate for solution for infusion) is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving TECENTRIQ. |
0 |
| Tecentriq (atezolizumab) [product monograph]. HC. |
TECENTRIQ (atezolizumab) in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression on tumour-infiltrating immune cells (IC) covering ≥ 1% of the tumour area, and who have not received prior chemotherapy for metastatic disease. |
1 |
| Tepmetko (tepotinib) [product monograph]. HC. |
TEPMETKO (tepotinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymalepithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations. |
2 |
| Tibsovo (ivosidenib) [product monograph]. HC. |
TIBSOVO (ivosidenib) in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy. |
6 |
| Tibsovo (ivosidenib) [product monograph]. HC. |
TIBSOVO (ivosidenib) monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. |
4 |
| Trodelvy (sacituzumab govitecan) [product monograph]. HC. |
TRODELVY (sacituzumab govitecan) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. |
2 |
| Truqap (capivasertib) [product monograph]. HC. |
TRUQAP (capivasertib tablets), in combination with fulvestrant, is indicated for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. |
21 |
| Tukysa (tucatinib) [product monograph]. HC. |
TUKYSA (tucatinib) is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination. |
1 |
| Tykerb (lapatinib) [product monograph]. HC. |
TYKERB (lapatinib tablets) is indicated for in combination with capecitabine, for the treatment of patients with metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressed on taxanes and anthracycline before starting this therapy. In addition, patients should have progressed on prior trastuzumab therapy in the metastatic setting. |
1 |
| Vectibix (panitumumab) [product monograph]. HC. |
VECTIBIX (panitumumab for injection) is indicated for the treatment of previously untreated patients with non-mutated (wild-type) RAS metastatic colorectal carcinoma (mCRC) in combination with FOLFOX (infusional 5-fluorouracil, leucovorin, and oxaliplatin). |
0 |
| Vectibix (panitumumab) [product monograph]. HC. |
VECTIBIX (panitumumab for injection) is indicated as monotherapy for the treatment of patients with non-mutated (wild-type) RAS mCRC after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. |
1 |
| Verzenio (abemaciclib) [product monograph]. HC. |
VERZENIO (abemaciclib) is indicated in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features. |
3 |
| Verzenio (abemaciclib) [product monograph]. HC. |
VERZENIO (abemaciclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy, in combination with fulvestrant in women with disease progression following endocrine therapy, or as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens. |
6 |
| Vitrakvi (larotrectinib) [product monograph]. HC. |
VITRAKVI (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumours that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation. |
3 |
| Voranigo (vorasidenib) [product monograph]. HC. |
VORANIGO (vorasidenib tablets) is indicated for the treatment of Grade 2a astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and pediatric patients aged 12 years and older following surgical intervention. |
20 |
| Vyloy (zolbetuximab) [product monograph]. HC. |
Vyloy (zolbetuximab for injection), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive as determined by a validated test. |
1 |
| Xalkori (crizotinib) [product monograph]. HC. |
XALKORI (crizotinib) is indicated for use as monotherapy in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
1 |
| Xalkori (crizotinib) [product monograph]. HC. |
XALKORI (crizotinib) is indicated for use in patients with ROS1-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
1 |
| Xospata (gilteritinib) [product monograph]. HC. |
XOSPATA (gilteritinib tablets) is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation. |
8 |
| Yervoy (ipilimumab) [product monograph]. HC. |
YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with metastatic NSCLC, expressing PD-L1 ≥ 1% as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC. |
1 |
| Yervoy (ipilimumab) [product monograph]. HC. |
YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC. |
1 |
| Yervoy (ipilimumab) [product monograph]. HC. |
YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer after prior fluoropyrimidine-based therapy in combination with oxaliplatin or irinotecan. |
0 |
| Yervoy (ipilimumab) [product monograph]. HC. |
YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC), with tumour cell PD-L1 expression ≥ 1% as determined by a validated test, and no prior systemic therapy for metastatic ESCC. |
1 |
| Zelboraf (vemurafenib) [product monograph]. HC. |
ZELBORAF (vemurafenib) is indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status. |
2 |
| Zykadia (ceritinib) [product monograph]. HC. |
ZYKADIA (ceritinib) as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
1 |
| Zykadia (ceritinib) [product monograph]. HC. |
ZYKADIA (ceritinib) as monotherapy is indicated for the treatment of adult patients with ALK-positive locally advanced (not amenable to curative therapy) or metastatic NSCLC who have progressed on or who were intolerant to crizotinib. |
1 |
| Modeyso (dordaviprone) [package insert]. FDA. |
MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. |
1 |
| Inluriyo (imlunestrant) [package insert]. FDA. |
INLURIYO is an estrogen receptor antagonist indicated for treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. |
1 |
| Vanflyta (quizartinib) [package insert]. FDA. |
VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. |
3 |
| Imbruvica (ibrutinib) [package insert]. FDA. |
IMBRUVICA is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) with 17p deletion. |
1 |