Dr. Bryce on the FDA Approval of Rucaparib in BRCA-Mutant mCRPC

Alan H. Bryce, MD, assistant professor of medicine and medical director of the Genomic Oncology Clinic, Mayo Clinic, discusses the accelerated approval of rucaparib (Rubraca) for the treatment of adult patients with BRCA mutation (germline and/or somatic)—associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor–directed therapy and a taxane-based chemotherapy.

The accelerated approval is based on findings from the ongoing phase 2 TRITON2 trial (NCT02952534), in which the PARP inhibitor demonstrated a 44% confirmed objective response rate (ORR) in 62 evaluable patients with BRCA1/2-mutant mCRPC.

The results of the TRITON2 trial confirm historical data showing the efficacy of PARP inhibitors in BRCA-mutant prostate cancer, says Bryce. The regulatory decision marks the first approval for a biomarker-driven targeted therapy in prostate cancer, says Bryce. With this approval, patients with BRCA-mutant mCRPC now have access to an extremely effective and attractive treatment option, concludes Bryce.