Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy treatment option for the treatment of adult patients with metastatic castration-resistant prostate cancer whose tumors harbor BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
This is written in the approval document as:
As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
Citation
Olaparib (Tablet) Monotherapy, 2023, version number 3, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gynaecology/588-olaparib-tablet-monotherapy.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 | Olaparib | |
| Sensitivity (+) | BRCA2 oncogenic variants | Prostate Adenocarcinoma | Olaparib | |
| Sensitivity (+) | BRCA1 pathogenic variants | Prostate Adenocarcinoma | Olaparib | |
| Sensitivity (+) | BRCA2 pathogenic variants | Prostate Adenocarcinoma | Olaparib |