FDA approves niraparib combination for BRCA2-mutated metastatic prostate cancer

The FDA approved niraparib and abiraterone acetate (Akeega) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test. The approval was announced December 12, 2025.

Efficacy was evaluated in AMPLITUDE, a randomized, double-blind trial of 696 patients with HRR gene-mutated metastatic castration-sensitive prostate cancer. Patients received niraparib and abiraterone acetate plus prednisone, or placebo and abiraterone acetate plus prednisone. All continued androgen deprivation therapy. In an exploratory analysis of 323 patients with BRCA2 mutations, the FDA reported a radiographic progression-free survival hazard ratio of 0.46 (95% CI: 0.32, 0.66). Median radiographic progression-free survival was not estimable (95% CI: 41, NE) with niraparib and abiraterone acetate, compared with 26 months (95% CI: 18, 28) with placebo and abiraterone acetate. The prescribing information includes warnings for myelosuppression, hepatotoxicity, cardiovascular adverse reactions and other risks.