Johnson & Johnson’s AKEEGA (niraparib plus abiraterone) received a positive CHMP opinion for BRCA1/2-mutated metastatic hormone-sensitive prostate cancer, supported by Phase 3 AMPLITUDE trial results showing significant rPFS benefit.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of AKEEGA® (niraparib plus abiraterone acetate) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations.
If approved by the European Commission, AKEEGA would offer a targeted combination approach for men whose prostate cancer is driven by defects in DNA repair pathways. Niraparib is a PARP inhibitor designed to exploit tumor vulnerability in BRCA-mutated cancers, while abiraterone works by suppressing androgen production, a key growth signal in prostate cancer.
The CHMP recommendation is supported by positive Phase 3 AMPLITUDE trial results (NCT04497844), which compared niraparib plus abiraterone acetate and prednisone (AAP) against placebo plus AAP in 696 patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations. The study met its primary endpoint, showing a significant improvement in radiographic progression-free survival (rPFS).
Patients with BRCA1/2 mutations (n=191) derived the strongest benefit. Median rPFS was not reached in the niraparib/AAP arm, compared with 26 months in the placebo group, translating to a 48% reduction in the risk of radiographic progression or death (HR 0.52). The combination also delayed symptomatic progression by 56% (HR 0.44).
An interim overall survival analysis showed an early trend favoring niraparib/AAP, with a 25% reduction in risk of death, though results were not yet statistically significant. Follow-up continues as data mature.
Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine highlighted that patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer tend to have a more aggressive disease, shorter survival, and few treatment choices before progressing to metastatic castration-resistant prostate cancer. She noted that, if approved, the niraparib plus abiraterone tablet could provide an earlier targeted treatment option to address this unmet need before the cancer becomes harder to treat.
In April 2016, Janssen Biotech, a Johnson & Johnson company, signed a global collaboration and licensing agreement with TESARO (later acquired by GSK in 2019), securing exclusive rights to develop niraparib for prostate cancer worldwide, excluding Japan.
mHSPC remains an aggressive form of prostate cancer, and BRCA1/2 mutations are associated with poorer prognosis. The positive CHMP opinion underscores the growing importance of genetic testing in guiding treatment decisions and improving long-term survival outcomes.
References
EMA CHMP positive opinion for Akeega (niraparib & abiraterone acetate) — European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/variation/akeega
Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations, 30 January 2026, Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
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
Attard G et al, Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025 Dec;31(12):4109-4118. Epub 2025 Oct 7. PMID: 41057655; PMCID: PMC12705445. https://doi.org/10.1038/s41591-025-03961-8