FDA Approvals

FDA Approves Janssen Biotech's Akeega for BRCA2-Mutated mCSPC

Bloomberg Law Dec 12, 2025

The FDA approved Janssen Biotech's Akeega (niraparib and abiraterone acetate) for treating BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). The approval was based on statistically significant improvements in radiographic progression-free survival shown in the AMPLITUDE trial.

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