What Johnson & Johnson’s AKEEGA opinion means for PARP inhibitors beyond castration resistance
Find out how Johnson & Johnson’s CHMP opinion for AKEEGA could shift prostate cancer treatment toward earlier, biomarker-guided precision therapy.
Pharma & Biotech
Pharma & Biotech
FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer
Johnson & Johnson (J&J) announced on December 12, 2025, that the U.S. Food and Drug Administration approved AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate, alongside prednisone, for treating BRCA2-mutated metastatic castration-sensitive prostate cancer. The regulatory nod, based on the pivotal AMPLITUDE trial, makes AKEEGA the first precision medicine combination approved for this high-risk