CHMP grants positive opinion for J&J’s Akeega use

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).

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