Shots:
- The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPC
- sNDA was backed by 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 48%, plus showed prolonged time to symptomatic progression by 56%, & a favorable OS trend, with 25% reduction in death risk
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
Related News:- Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)
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