Johnson & Johnson Reports the US FDA’s sNDA Acceptance & Priority Review of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPCsNDA 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…