In a recent statement, the U.S. Food and Drug Administration (FDA) has authorized regular approval to rucaparib (Rubraca) for adults with metastatic castration-resistant prostate cancer (mCRPC) harboring deleterious BRCA mutations—either germline or somatic—who have previously received androgen receptor-directed therapy. Patient selection requires an FDA-approved companion diagnostic.
This decision, announced on December 17, 2025, converts rucaparib’s accelerated approval from 2020 into full approval following confirmatory evidence from the TRITON3 trial (NCT02975934).
Key Trial Findings
TRITON3 enrolled 405 patients with mCRPC who had progressed on prior androgen receptor pathway inhibitors and had not received chemotherapy in the castration-resistant setting. Participants were randomized 2:1 to rucaparib or physician’s choice of enzalutamide, abiraterone acetate, or docetaxel.
- Primary Endpoint: Radiographic progression-free survival (rPFS)
- Results in BRCA-mutated patients (n=302):
- Median rPFS: 11.2 months with rucaparib vs. 6.4 months with physician’s choice (HR 0.50; p<0.0001)
- Median overall survival: 23.2 vs. 21.2 months (not statistically significant)
- Exploratory analysis in ATM-mutated patients showed no meaningful benefit, indicating efficacy is primarily driven by BRCA mutations.
Safety and Dosing
Rucaparib carries warnings for myelodysplastic syndrome/acute myeloid leukemia and embryo-fetal toxicity. The recommended dose is 600 mg orally twice daily (total 1,200 mg/day) until disease progression or unacceptable toxicity.
Full prescribing details will be available on Drugs@FDA.
