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/2022/209115s013lbl.pdf. Revised December 2022. Accessed October 30, 2024.

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 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

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
Sensitivity (+)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Rucaparib
Sensitivity (+)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Rucaparib
Sensitivity (+)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Rucaparib
Sensitivity (+)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib
Sensitivity (+)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib
Sensitivity (+)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib
Sensitivity (+)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Rucaparib
Sensitivity (+)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Rucaparib
Sensitivity (+)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Rucaparib
Sensitivity (+)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Rucaparib
Sensitivity (+)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Rucaparib
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Rucaparib
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Rucaparib
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Rucaparib
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Rucaparib