Johnson & Johnson (J&J) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and recommended an indication extension for Akeega (niraparib and abiraterone acetate dual action tablet).
The CHMP recommends the use of niraparib and abiraterone acetate with prednisone or prednisolone (AAP), along with androgen deprivation therapy (ADT), specifically for patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations.
Its decision is based on data from the Phase III AMPLITUDE study involving 696 patients with mHSPC and HRR gene alterations.
This study showed that niraparib/AAP improved radiographic progression-free survival (rPFS), particularly in BRCA1/2 mutation carriers (n=191), where median rPFS was not reached versus 26 months for placebo plus AAP, reducing progression or death risk by 48%. Time to symptomatic progression was significantly prolonged by 56%. An interim analysis indicated a 25% reduction in mortality risk.
J&J innovative medicine oncology EMEA therapeutic area head and senior director Henar Hevia said: “Patients with metastatic hormone-sensitive prostate cancer who carry BRCA1/2 mutations face a more aggressive disease with survival outcomes that are significantly shorter, compared to those without these mutations, with limited treatment options before their disease progresses to metastatic castration-resistant prostate cancer.
“Pending approval, the niraparib and abiraterone acetate dual action tablet will offer a targeted treatment strategy with the potential to address this urgent medical need earlier in the metastatic pathway, before the disease becomes more resistant.”
In December 2025, J&J received the US Food and Drug Administration (FDA) approval for Rybrevant Faspro, a subcutaneously (SC) administered therapy to treat patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
