Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Rucaparib in patients with Prostate Adenocarcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. 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 October 6, 2026.

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