Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized niraparib with abiraterone acetate (Akeega) in combination with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

This is written in the approval document as:

Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

Citation

Janssen-Cilag International N.V. Akeega (abiraterone acetate and niraparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf. Revised March 2026. Accessed August 2, 2026.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-04-19	European Medicines Agency	Indication received approval from the European Commission.