Posted by Michael Wonder on 11 Aug 2023
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA mutated metastatic castration-resistant prostate cancer
11 August 2023 - Today, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech), with prednisone, for adult patients with deleterious or suspected deleterious BRCA mutated castration-resistant prostate cancer, as determined by an FDA approved test.
Efficacy was evaluated in Cohort 1 of MAGNITUDE, a randomised, double-blind, placebo controlled trial enrolling 423 patients with homologous recombination repair gene mutated castration-resistant prostate cancer.
