- The FDA has granted accelerated approval to rucaparib for the treatment of patients with BRCA-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
- The recommended dose is 600 mg twice daily with or without food.
- Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently, or should have had bilateral orchiectomy.
Why this matters
- Rucaparib is the first PARP inhibitor to receive approval for patients with mCRPC who harbor a deleterious BRCA mutation.
- Approval was based on the ongoing TRITON2 trial.
- 115 previously treated patients with BRCA-mutated mCRPC received rucaparib and concomitant GnRH analog or had prior bilateral orchiectomy.
- Objective response rate in 62 evaluable patients was 44% (95% CI, 31%-57%).
- 27 patients had confirmed objective responses, of which 15 had duration of response (DOR) of ≥6 months.
- Median DOR was not evaluable (95% CI, 6.4 months-not evaluable).
- The range for DOR was 1.7-24+ months.
- The most common adverse reactions (≥20%) were fatigue, nausea, anemia, increased aspartate aminotransferase/alanine aminotransferase, decreased appetite, rash, and constipation.
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