The FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
Efficacy was evaluated in cohort 1 of MAGNITUDE, a randomized, double-blind, placebo-controlled trial enrolling 423 patients with homologous recombination repair (HRR) gene-mutated mCRPC. Patients
AUGUST 14, 2023