FDA Greenlights Niraparib–Abiraterone–Prednisone for BRCA2‑Mutated Metastatic Castration‑Sensitive Prostate Cancer: Implications and Practical Considerations

Highlights

– The FDA approved niraparib plus abiraterone acetate and prednisone for adults with deleterious or suspected deleterious BRCA2‑mutated metastatic castration‑sensitive prostate cancer (CSPC), using an FDA‑approved test to determine BRCA2 status.

– Approval was based on the randomized, double‑blind AMPLITUDE trial: a significant rPFS benefit in the homologous recombination repair (HRR)–mutated population was driven primarily by effects in the BRCA2‑mutated subgroup (exploratory analysis HR for rPFS 0.46).