- The EMA has received an application for label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone to treat adults with mHSPC & HRR gene alterations
- Submission was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC
- Trial met its 1EP of improved rPFS with key 2EP of time to symptomatic progression (TSP) & showed a favorable early OS trend; data was presented at ASCO 2025
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
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