August 11, 2023

FDA Approves Akeega for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

The Food and Drug Administration 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 castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.

A statistically significant improvement in rPFS for niraparib and abiraterone acetate plus prednisone compared to placebo and abiraterone acetate plus prednisone was observed in BRCAm patients with a median of 16.6 months vs 10.9 months (HR 0.53; 95% CI 0.36, 0.79; p=0.0014).

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