Regulatory approval

Published by the Health Service Executive. Approved

Niraparib in combination with abiraterone acetate (Akeega) and predniSONE/prednisoLONE for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

This is written in the approval document.

Reimbursement

CDS

Citation

Niraparib and Abiraterone acetate (Akeega) and prednisoLONE Therapy, 2025, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6448/848_v2_Niraparib_abiraterone.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HSE (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HSE (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
HSE (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone