Rubraca (rucaparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Clovis Oncology, Inc. Rubraca (rucaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf. Revised December 2025. Accessed December 23, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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 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.	4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Rucaparib	FDA
Sensitivity (+)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Rucaparib	FDA
Sensitivity (+)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Rucaparib	FDA
Sensitivity (+)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Rucaparib	FDA
Sensitivity (+)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib	FDA
Sensitivity (+)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib	FDA
Sensitivity (+)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib	FDA
Sensitivity (+)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib	FDA
Sensitivity (+)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Rucaparib	FDA
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Rucaparib	FDA