Regulatory approval

Published by the Food and Drug Administration.

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.

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Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) BRCA1 oncogenic variants Prostate Adenocarcinoma Rucaparib
FDA (1) BRCA1 pathogenic variants Prostate Adenocarcinoma Rucaparib
FDA (1) BRCA2 oncogenic variants Prostate Adenocarcinoma Rucaparib
FDA (1) BRCA2 pathogenic variants Prostate Adenocarcinoma Rucaparib