Rucaparib (Rubraca, Clovis Oncology, Inc.), a PARP inhibitor, on May 15 received accelerated approval from FDA for use in men with metastatic castration-resistant prostate cancer (mCRPC) associated with a deleterious BRCA mutation.

The approval is based on findings from TRITON2, an ongoing multicenter, single-arm clinical trial that enrolled 115 patients with BRCA-mutated mCRPC previously treated with androgen-receptor directed therapy and taxane-based chemotherapy.

Investigators assessed objective response rate (ORR) and duration of response (DOR) in 62 patients with measurable disease. The confirmed ORR was 44%. The median DOR was not evaluable, but the range 1.7 to 24 or more months. Fifteen of the 27 (56%) patients with confirmed objective responses had a DOR of at least 6 months. 

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The most common adverse reactions (occurring in 20% or more of patients) among all 115 patients with BRCA-mutated mCRPC were fatigue, nausea, anemia, increased ALT/AST, decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhea, FDA said in a press release.

The recommended rucaparib dose is 600 mg orally twice daily with or without food. Patients receiving rucaparib for mCRPC should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, according to the FDA.


FDA press release. FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer.