FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.

ABSTRACT: On August 11, 2023, the FDA approved the fixed-dose combination of niraparib and abiraterone acetate (AA), with prednisone (AAP), for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer, as determined by an FDA-approved test. Substantial evidence of effectiveness was demonstrated by cohort 1 of MAGNITUDE (NCT03748641), a multi-cohort study. Cohort 1 was a double-blind trial that randomly assigned 423 patients with metastatic castration-resistant prostate cancer and homologous recombination repair mutations to receive niraparib 200 mg daily plus AA 1,000 mg daily and prednisone versus placebo plus AAP. The presence of BRCAm was a stratification factor. There was a statistically significant improvement

SUBMITTER: Maguire WF 

PROVIDER: S-EPMC12276826 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature