FDA has granted an accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Rubraca is sponsored by Clovis Oncology Inc.
Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA-mutated (germline and/or somatic) mCRPC who were treated with androgen receptor-directed therapy and taxane-based chemotherapy. Patients received rucaparib 600 mg orally twice daily and concomitant GnRH analog or had prior bilateral orchiectomy.
Objective response rate and duration of response were assessed in 62 patients with measurable disease. The confirmed ORR was 44% (95% CI: 31, 57). Median DOR was not evaluable (NE; 95% CI: 6.4, NE). The range for the DOR was 1.7-24+ months. Fifteen of the 27 (56%) patients with confirmed objective responses had a DOR of ≥6 months.