Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Organizations Biomarkers Cancer types Therapies
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