Shots:
- The US FDA has approved J&J‘s Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC
- Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC
- Trial met its 1EP of improved rPFS by 54%, with prolonged time to symptomatic progression by 59%
Ref: J&J | Image: J&J |Press Release
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