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.

Type Biomarker(s) Cancer type Therapy(ies)
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