The European Medicines Agency (EMA) has approved an extension of indication for Akeega (Janssen-Cilag International) — a dual‑action tablet combining niraparib and abiraterone acetate — to be used with prednisone or prednisolone plus androgen‑deprivation therapy for the treatment of adult patients with metastatic hormone‑sensitive prostate cancer (mHSPC) harboring BRCA1/2 (germline or somatic) mutations.

Patients with mHSPC who harbor BRCA1/2 mutations experience more aggressive disease progression and shorter survival compared with those without these genetic alterations. Approximately 1 in 4 patients with mHSPC carry homologous recombination repair (HRR) gene alterations, most commonly BRCA1/2, which are associated with faster disease advancement. 

Current treatment approaches for mHSPC do not specifically target these underlying DNA repair deficiencies, creating significant unmet medical needs for this high-risk population. Most patients ultimately develop resistance to available therapies and progress to metastatic castration-resistant prostate cancer (mCRPC), which has limited long-term survival prospects.

Akeega contains niraparib, which blocks PARP-1 and PARP-2 enzymes that help repair damaged DNA in dividing cells, preventing cancer cells from repairing DNA damage and causing cell death. Abiraterone acetate stops testosterone production by blocking the CYP17 enzyme, helping slow prostate cancer growth because the cancer requires testosterone to survive and grow.

Clinical Evidence 

The Committee for Medicinal Products for Human Use’s recommendation stems from positive results from the ongoing phase 3 AMPLITUDE study, which enrolled 696 patients with mHSPC and HRR gene alterations. Patients with BRCA1/2 mutations showed the greatest treatment benefit, with median radiographic progression-free survival not reached compared with 26 months for those receiving placebo plus abiraterone acetate and prednisone. 

The combination reduced the risk for radiographic progression or death by 48% and significantly prolonged time to symptomatic progression by 56% in patients with BRCA alterations. An early analysis showed a trend toward improved overall survival, with a 25% reduction in risk for death, though follow-up continues for data maturity. 

Safety Profile and Current Authorization 

The safety profile of Akeega remained consistent with that observed in mCRPC, for which the combination currently holds authorization. The most common grade 3/4 adverse events included anemia and hypertension, although treatment discontinuations due to adverse events remained low and side effects proved manageable with dose modifications and supportive care. 

Akeega received initial authorization in April 2023 throughout the European Economic Area for treating patients with BRCA-mutated mCRPC when chemotherapy is not clinically indicated. The medicine is available as tablets taken orally on an empty stomach once daily for as long as patients benefit or do not experience unacceptable side effects, and it requires a prescription for use.

Detailed recommendations will be included in the updated Summary of Product Characteristics, to be published on the EMA website in all official European Union languages following the European Commission’s decision on the marketing authorization change.