Prostate cancer is one of the most common cancers in men in Ireland, with about 3,940 men diagnosed each year. AKEEGA® received first approval worldwide with EC Authorisation. It was based on the results of the Phase 3 MAGNITUDE study, which showed that niraparib in combination with abiraterone acetate significantly improved radiographic progression-free survival in untreated patients with BRCA1/2 mutations. The treatment has been granted reimbursement in Ireland for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations. The study involved over 400 patients and showed promising results in terms of overall survival rates. Janssen has submitted a New Drug Application seeking FDA approval for this treatment.
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AKEEGA approved for the treatment of prostate cancer with BRCA1/2 mutations
