Johnson & Johnson (J&J) has announced that the MHRA has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate dual-action pill), with prednisone or prednisolone, in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic).
The decision means the UK has licensed the first precision medicine combination for patients with BRCA1/2-mutated mHSPC, marking an important step towards more personalised care and potential future NHS access for eligible patients across the UK.
Expert and company perspective on the MHRA marketing authorisation
“Whilst outcomes for advanced prostate cancer have improved notably over the last decade, prostate cancers with a BRCA mutation, which account for about one in 10 cases, still have shorter survival and worse outcomes,” said Professor Gerhardt Attard, Director of the University College London Cancer Institute and Medical Oncology Consultant at University College London Hospitals NHS Foundation Trust.* “Targeted treatments with poly-ADP ribose polymerase (PARP) inhibitors have had a big impact for breast and ovarian cancers when optimised for use early on in the treatment paradigm. I’m delighted that we now have the potential to benefit this group of patients with a poorer prognosis.”
This announcement represents an important step forward for men in the UK with BRCA1/2-mutated mHSPC,” said Dr John Fleming (pictured), Country Medical Director, Johnson & Johnson Innovative Medicine UK. “These patients haven’t historically had a treatment option tailored to the underlying biology of their disease. This authorisation expands the use of precision medicine to an earlier stage of BRCA1/2-mutated prostate cancer and provides a new treatment option that enables care to be tailored to the underlying biology of the disease.
Following MHRA authorisation, J&J will continue to work with relevant health technology assessment bodies and healthcare stakeholders to support potential future access for eligible patients across the UK.
Unmet need in mHSPC patients
Prostate cancer is the most diagnosed cancer in men in the UK, with about 64,000 men diagnosed every year,[vi] and around 20 per cent presenting with metastatic disease.[vii] The majority of cases are hormone-sensitive, with between 8 per cent and 12 per cent of patients with mHSPC having BRCA1/2 gene alterations.1,5
Patients with BRCA1/2 mutations often experience more aggressive disease, faster progression and shorter survival than those without these alterations.¹ This represents a significant unmet need that is not adequately addressed by existing treatment approaches.
References
[i] Olmos D et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Annals of Oncology. 2025. 36(10): 1190-1202.
[ii] Custodio-Cabello S et al. Prognostic value of germline mutations in metastatic hormone-sensitive prostate cancer (mHSPC),
Urologic Oncology: Seminars and Original Investigations. Volume 42, Issue 10, 2024. Pages 331.e13-331.e24. ISSN 1078-1439. https://doi.org/10.1016/j.urolonc.2024.05.010.
[iii] Attard G et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nature Medicine. 2025. 31:4109-4118.
[iv] Summary of Product Characteristics (SmPC). Akeega 50 mg/500 mg film-coated tablets.
[v] Summary of Product Characteristics (SmPC). Akeega 100 mg/500 mg film-coated tablets.
[vi] Prostate Cancer UK. Facts and figures. Available at: https://prostatecanceruk.org/prostate-information-and-support/risk-and-symptoms/about-prostate-cancer/facts-and-figures Last accessed: July 2026
[vii] Singh A, Arif Z, Birtle A. Leading from the front: Real-world treatment of metastatic hormone-sensitive prostate cancer in the Northwest of England. Clinical Oncology, 38. Available at: https://www.clinicaloncologyonline.net/article/S0936-6555(24)00437-0/abstract Last accessed: July 2026
