Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized niraparib with abiraterone acetate 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 June 2023. Accessed March 5, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| 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 |