Johnson & Johnson has 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).
“Patients with BRCA-mutated metastatic prostate cancer often experience rapid progression on the current standard of care, highlighting a significant unmet need for more personalised treatment approaches that address the underlying biology of their disease,” said Elena Castro, medical oncologist, Hospital 12 de Octubre, Madrid.
“Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression.”
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 homologous recombination repair (HRR) gene alterations. The primary analysis of the study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).
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, corresponding to a reduction in the risk of radiographic progression or death by 48%. Treatment with the niraparib/AAP combination also significantly prolonged the time to symptomatic progression in patients with BRCA mutations. The second interim analysis of overall survival was consistent with the first interim analysis and favoured the niraparib/AAP combination, with a 20% reduction in risk of death in patients with BRCA mutations. Follow-up is ongoing.
“This expanded indication for niraparib and abiraterone acetate reflects our commitment to delivering transformative innovation across the prostate cancer continuum,” said Charles Drake, vice president, prostate cancer and immunotherapy disease area leader, Johnson & Johnson.
“Niraparib and abiraterone acetate is the first precision-medicine combination treatment approved for patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer and is supported by strong clinical data demonstrating a clinically meaningful delay in disease progression.”
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.
“Today’s EC approval shifts the treatment paradigm and brings new hope to those facing a metastatic prostate cancer diagnosis,” said Henar Hevia, senior director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson.
“By bringing niraparib and abiraterone acetate earlier into the treatment pathway, in the hormone-sensitive setting, we can intervene at a point where it may have the greatest impact in helping change the trajectory of the disease for patients with BRCA1/2-mutated tumours.”