The European Commission approved an expanded indication for AKEEGA (niraparib and abiraterone acetate) with prednisone or prednisolone plus androgen deprivation therapy for patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer. The decision was supported by Phase 3 AMPLITUDE data showing a 48% reduction in the risk of radiographic progression or death in BRCA1/2-mutated patients. In this subgroup, the overall survival analysis favored the regimen with a 20% lower risk of death.

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