Posted by Michael Wonder on 15 May 2020
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer
15 May 2020 - Today the FDA granted accelerated approval to rucaparib (Rubraca, Clovis Oncology) 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.
Efficacy was investigated in TRITON2, an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA-mutated (germline and/or somatic) mCRPC who had been 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.
