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 June 2023. Accessed March 5, 2024.

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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Abiraterone acetate, Niraparib, Prednisolone