Johnson & Johnson today announced that the European Commission (EC) has approved an indication extension for AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic).
Prostate cancer is Ireland’s most prevalent male cancer, with approximately 4,000 annual diagnoses, frequently detected through prostate-specific antigen (PSA) testing.[3] Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.[4] Ireland ranks seventh globally and fourth in Europe in age-adjusted incidence rates, with 99.8 cases per 100,000 population annually.[5],[6]
Most patients with metastatic hormone-sensitive prostate cancer (mHSPC) ultimately develop resistance to available therapies and progress to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive stage of disease with limited long-term survival.[7]
Approximately one in four patients with mHSPC harbour homologous recombination repair gene alterations (HRR) – most commonly BRCA1/2 – which are associated with faster disease progression and often shorter survival.[7] As current mHSPC treatment approaches are not biomarker-selected and do not specifically address underlying DNA repair deficiencies, this high-risk population faces a significant unmet need for novel therapies.[8]
Dr. Lynda Corrigan, Consultant Medical Oncologist at Tallaght University Hospital said: “Metastatic hormone-sensitive prostate cancer patients with BRCA1/2 mutations currently face a challenging disease with poor outcomes to standard first line treatments, and shorter survival. The marketing authorisation of this dual action tablet is an important development, offering a new treatment approach that can intervene earlier and target the disease’s genetic drivers, with the potential to improve long- term outcomes for these patients.”
“At Johnson & Johnson we are committed to advancing truly innovative, precision medicine solutions for patients,” said Brid Seoighe, Medical Director, Johnson & Johnson Innovative Medicine Ireland. “Building on our deep legacy spanning nearly two decades in the treatment of prostate cancer, we are driven by the belief that the next frontier of care requires more personalised treatment approaches that address the specific drivers of high-risk disease. This announcement is an important step towards integrating targeted precision medicine into routine care.”
The approval is supported by data from the Phase 3 AMPLITUDE study, which evaluated the efficacy and safety of the niraparib/AAP combination compared with placebo plus AAP in 696 patients with mHSPC and HRR gene alterations.[1] The study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).[1]
Patients with BRCA1/2 mutations showed the greatest benefit of treatment with the niraparib/AAP combination (n=191), as after 30.7 months of follow-up, the median rPFS was not yet reached compared to 26 months in patients treated with the placebo plus AAP (n=196), corresponding to a reduction in the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001.[2],[9]
Treatment with the niraparib/AAP combination also significantly prolonged the time to symptomatic progression in patients with BRCA alterations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001).[1]
The second interim analysis of overall survival was consistent with the first interim analysis and favoured the niraparib/AAP combination, with a 20 percent reduction in risk of death (HR 0.80, 95 percent CI, 0.58-1.11) in patients with BRCA mutations.[1] Follow-up is ongoing.[10]
The safety profile of the niraparib/AAP combination in mHSPC was consistent with that observed in mCRPC, for which the niraparib/AAP combination is currently authorised.[1],[11] The most common Grade 3/4 adverse events (AEs) with the niraparib/AAP combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low and AEs were manageable with dose modifications and supportive care.[1]
Data from the AMPLITUDE study were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and selected for inclusion in the Best of ASCO and ASCO Press Programme.[12]
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