Akeega (abiraterone acetate and niraparib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 4
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). 8

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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 (2) BRCA1 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisolone
EMA (2) BRCA2 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisolone
EMA (2) BRCA1 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisolone
EMA (2) BRCA2 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Niraparib, Prednisolone