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

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

The FDA approved once‑daily niraparib plus abiraterone acetate and prednisone for adults with deleterious or suspected deleterious BRCA2‑mutated metastatic castration‑sensitive prostate cancer (CSPC), based on rPFS and interim overall survival benefits in the AMPLITUDE trial.
MAGNITUDE final analyses: Niraparib + Abiraterone improves symptoms and delays chemotherapy but not overall survival in HRR‑altered mCRPC

MAGNITUDE final analyses: Niraparib + Abiraterone improves symptoms and delays chemotherapy but not overall survival in HRR‑altered mCRPC

Final MAGNITUDE results show niraparib combined with abiraterone–prednisone improves radiographic PFS, time to symptomatic progression and delays cytotoxic chemotherapy in HRR‑altered mCRPC (notably BRCA1/2), preserves patient‑reported quality of life, but did not demonstrate a statistically significant overall survival benefit in the primary analysis.