Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted accelerated approval to rucaparib 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. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for rucaparib.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Rucaparib
FDA (2)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Rucaparib
FDA (2)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Rucaparib
FDA (2)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Rucaparib

Contributions

Date	Contributor	Description
2025-12-23	Van Allen lab	On 2025-12-17, the US FDA granted regular approval to rucaparib for the treatment of patients with BRCA mutated mCRPC, which had previously received accelerated approval in 2020.
2025-12-17	Food and Drug Administration	Indication received traditional approval.
2024-10-30	Van Allen lab	Initial access of FDA approvals