EMA Approves Akeega for BRCA-Mutated Early Metastatic Prostate Cancer

The European Medicines Agency (EMA) has approved Akeega (Janssen-Cilag) for use in adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) who carry BRCA1/2 mutations. Akeega is a dual-action oral tablet combining niraparib, a PARP inhibitor that blocks DNA repair in cancer cells, and abiraterone acetate, which suppresses testosterone production, given with prednisone or prednisolone and androgen-deprivation therapy.

Patients with BRCA1/2 mutations experience more aggressive disease and shorter survival compared with other mHSPC patients. Current therapies do not specifically target these DNA repair deficiencies, leaving a high-risk population with unmet medical needs.

Approval was based on results from the phase 3 AMPLITUDE study of 696 patients with homologous recombination repair (HRR) gene alterations. Among those with BRCA1/2 mutations, Akeega significantly improved outcomes: median radiographic progression-free survival was not reached versus 26 months for the control group, reducing the risk of progression or death by 48%, and delaying symptomatic progression by 56%. Early data also suggest a 25% reduction in risk of death.

The safety profile was consistent with previous use in metastatic castration-resistant prostate cancer (mCRPC), with anemia and hypertension the most common severe side effects. The drug is taken once daily on an empty stomach, with dose adjustments as needed, and requires a prescription.

Das, J. (2026, February 2). Dual‑action tablet gets EU nod for early prostate cancer. Medscape Europe. https://www.medscape.com/viewarticle/dual-action-tablet-gets-eu-nod-early-prostate-cancer-2026a100038l