Dr. Burgess on the FDA Accelerated Approval of Rucaparib in BRCA+ mCRPC

Earle Burgess, MD, an associate professor of medicine at Levine Cancer Institute, Atrium Health, discusses the FDA accelerated approval of rucaparib (Rubraca) in BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).

In May 2020, the FDA granted an accelerated approval to rucaparib for the treatment of adult patients with germline or somatic BRCA-mutant mCRPC who have received prior androgen receptor–directed therapy and taxane-based chemotherapy.

The regulatory decision was based on findings from the phase 2 TRITON2 study, in which rucaparib induced a 43.9% overall response rate and a 52% confirmed prostate-specific antigen response rate in patients with mCRPC who harbored BRCA1/2 mutations.

Notably, the approval of rucaparib is more restrictive in terms of eligibility compared with the FDA approval of olaparib (Lynparza), which is indicated for patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga), Burgess says.

The confirmatory phase 3 TRITON3 trial (NCT02975934) is ongoing to further evaluate rucaparib in patients with HRR-deficient mCRPC, concludes Burgess.