The European Commission has approved an expanded indication for Akeega (niraparib and abiraterone acetate), a dual action tablet developed by Johnson & Johnson (J&J), for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC). The regimen is administered with prednisone or prednisolone in combination with androgen deprivation therapy.
This represents the first biomarker-selected precision therapy authorized for mHSPC in Europe, moving PARP inhibition earlier in the prostate cancer treatment pathway than any prior approval. Akeega was first authorized in the EU in April 2023 for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC); the March 2026 decision extends its use to the hormone-sensitive setting, where approximately one in ten patients harbor BRCA1/2 alterations.
The approval covers patients with germline and/or somatic BRCA1/2 mutations. The dual action tablet combines niraparib, a PARP1/2 inhibitor, with abiraterone acetate, a CYP17 inhibitor that blocks androgen biosynthesis. The rationale for combining these mechanisms rests on simultaneous disruption of DNA damage repair and androgen receptor signaling, exploiting synthetic lethality in tumors with homologous recombination repair deficiencies while suppressing a pathway that drives prostate cancer growth.
The decision is supported by results from the Phase III AMPLITUDE trial, a randomised, double-blind, placebo-controlled study that enrolled 696 patients with HRR gene-altered mHSPC across 32 countries. Among patients with BRCA1/2 mutations (n=387), the niraparib and abiraterone acetate combination reduced the risk of radiographic progression or death by 48% compared with placebo plus abiraterone acetate and prednisone (hazard ratio 0.52, 95% CI 0.37–0.72, p<0.0001). Median radiographic progression-free survival had not been reached in the combination arm after 30.7 months of follow-up, versus 26 months in the control arm. Time to symptomatic progression was also prolonged (HR 0.44, 95% CI 0.29–0.68, p=0.0001). A second interim analysis of overall survival showed a 20% reduction in risk of death (HR 0.80, 95% CI 0.58–1.11), consistent with earlier analyses, though follow-up is ongoing. The safety profile was consistent with that observed in the mCRPC setting, with anemia and hypertension as the most common Grade 3/4 adverse events. Treatment discontinuations due to adverse events remained low, the company said. AMPLITUDE data were presented at the 2025 American Society of Clinical Oncology Annual Meeting.
The mHSPC treatment approval arrives in a landscape already shaped by several ADT intensification strategies, including abiraterone acetate alone, enzalutamide, apalutamide, and the darolutamide-docetaxel triplet regimen. None of these prior options, however, are selected by tumor genomics. Patients with BRCA metastatic prostate cancer tend to progress faster on standard regimens, and until now, PARP inhibitor-based therapies were reserved for the castration-resistant setting. The Akeega dual action tablet joins a competitive landscape that includes other PARP inhibitor combinations authorized in mCRPC, such as olaparib plus abiraterone (AstraZeneca/MSD) and talazoparib plus enzalutamide (Pfizer), though neither has yet received approval for mHSPC. The approval also reinforces the case for routine genomic testing at mHSPC diagnosis, a practice not yet universally adopted. Overall survival data from AMPLITUDE remain immature, and how this regimen will be sequenced alongside existing doublet and triplet approaches in clinical practice is yet to be defined.