European Commission approves Johnson & Johnson’s AKEEGA (niraparib and abiraterone acetate) with ADT for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer based on Phase 3 AMPLITUDE trial results.
Written By: Katherashala Dharan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
The European Commission (EC) has approved an indication extension for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for adults with metastatic hormone-sensitive prostate cancer (mHSPC) harboring germline or somatic BRCA1/2 mutations (BReast CAncer gene).
The approval introduces a precision-medicine treatment option earlier in the prostate cancer treatment pathway for patients with BRCA-mutated disease, which is often associated with aggressive progression.
The decision is supported by results from the Phase 3 AMPLITUDE trial (NCT04497844), which enrolled 696 patients with mHSPC and homologous recombination repair (HRR) gene alterations. Treatment with niraparib plus abiraterone acetate significantly improved the study’s primary endpoint of radiographic progression-free survival (rPFS) compared with placebo plus abiraterone acetate.
Among patients with BRCA1/2 mutations, the median rPFS was not reached with the niraparib combination versus 26 months with the control regimen, translating to a 48% reduction in the risk of radiographic progression or death (HR 0.52; p<0.0001). The combination also significantly delayed time to symptomatic progression (HR 0.44), while interim overall survival data showed a 20% reduction in risk of death with continued follow-up ongoing.
Readers interested in the full clinical trial design and earlier regulatory developments can review our previous coverage of the CHMP recommendation and detailed AMPLITUDE results:
The safety profile of the niraparib and abiraterone acetate combination in mHSPC was consistent with prior experience in metastatic castration-resistant prostate cancer, with anemia and hypertension reported as the most common Grade 3 or 4 adverse events.
AKEEGA is an oral dual-action tablet combining the PARP inhibitor niraparib with the CYP17 inhibitor abiraterone acetate. The therapy was previously authorized in the European Economic Area in April 2023 for BRCA-mutated metastatic castration-resistant prostate cancer.
Reference
European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC), 09 March 2026, European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)
J&J Scores CHMP Nod for AKEEGA in High-Risk Prostate Cancer, 31 January 2026, https://pharmacally.com/jj-scores-chmp-nod-for-akeega-in-high-risk-prostate-cancer/
A Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE), ClinicalTrials.gov ID NCT04497844, https://clinicaltrials.gov/study/NCT04497844
About the Writer
Katherashala Dharan Kumar, PharmD
A dedicated Clinical Researcher with expertise in medical and scientific writing clinical trials, drug safety, and healthcare innovation. Actively contributes to research publications and clinical documentation focused on improving patient outcomes through evidence-based practices and ethical research standards. Believe that every complex data point has a human story waiting to be told. Focusing on providing actionable insights for clinical research.