Regulatory approval

Published by the European Medicines Agency. Approved

Akeega is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline or somatic).

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
EMA (1) BRCA1 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
EMA (1) BRCA1 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
EMA (1) BRCA2 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
EMA (1) BRCA2 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisone
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
2026-08-02 Van Allen lab Initial curation of into moalmanac-db
2026-03-05 European Medicines Agency Indication received approval from the European Commission.