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

The FDA has approved Janssen Biotech's Akeega (niraparib and abiraterone acetate) for the treatment of BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This marks the first precision therapy for this specific genetic mutation in prostate cancer. The approval was based on the AMPLITUDE trial which showed a significant improvement in radiographic progression-free survival.