Posted by Michael Wonder on 12 Dec 2025
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
12 December 2025 - Today, the FDA approved niraparib and abiraterone acetate (Akeega, Janssen Biotech) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.
Efficacy was evaluated in AMPLITUDE, a randomised, double-blind trial in 696 patients with homologous recombination repair gene-mutated metastatic castration-sensitive prostate cancer.
