FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer

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 […]