Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved niraparib in combination with abiraterone acetate and prednisolone for reimbursement as a treatment option for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
This is written in the approval document as:
Niraparib in combination with abiraterone acetate (Akeega) and predniSONE/prednisoLONE for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
Citation
Niraparib and Abiraterone acetate (Akeega) and prednisoLONE Therapy, 2023, version number 1, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/genitourinary/848-niraparib-and-abiraterone-acetate-akeega-and-prednisolone-therapy.pdfTherapeutic 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 |