Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CD33 + status confers therapeutic sensitivity to Cytarabine, Daunorubicin, Gemtuzumab ozogamicin in patients with Acute Myeloid Leukemia.
Health Canada approved gemtuzumab ozogamicin in combination 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.
This statement is based on a regulatory approval from the Health Canada:
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.