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.pdf

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