NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an indication extension for AKEEGA (niraparib and abiraterone acetate dual action tablet).
The recommendation is for niraparib and abiraterone acetate with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT) and BRCA1/2 mutations (germline and/or somatic).
The CHMP recommendation is based on positive results from the Phase 3 AMPLITUDE study, which evaluated the efficacy and safety of the niraparib/AAP combination compared with placebo plus AAP in 696 patients with mHSPC and HRR gene alteration.
The study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).
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