Johnson & Johnson Receives CHMP Positive Opinion for AKEEGA® Dual‑Action Tablet in Metastatic Hormone‑Sensitive Prostate Cancer
Johnson & Johnson announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an extension of the indication for AKEEGA® (niraparib and abiraterone acetate dual‑action tablet) plus prednisone or prednisolone in combination with androgen deprivation therapy for adults with metastatic hormone‑sensitive prostate cancer (mHSPC) harboring BRCA1/2 mutations. This recommendation is based on positive Phase 3 AMPLITUDE trial results showing significant improvements in radiographic progression‑free survival and meaningful delays in symptomatic progression, potentially offering a targeted precision‑medicine option earlier in the metastatic prostate cancer treatment pathway. 
Johnson & Johnson Receives CHMP Positive Opinion for AKEEGA® Dual‑Action Tablet in Metastatic Hormone‑Sensitive Prostate Cancer