Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy or in combination with endocrine therapy as a treatment option for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
This is written in the approval document as:
As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. Lynparza's product information fromcites the OlympiA trial, where olaparib was compared against placebo for the treatment of patients with germline BRCA1/2 mutated and HER2-negative high risk early breast cancer.
Reimbursement
CDS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | BRCA1 pathogenic variants, HER2-negative | Invasive Breast Carcinoma | Olaparib | |
| HSE (1) | BRCA2 pathogenic variants, HER2-negative | Invasive Breast Carcinoma | Olaparib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-05-01 | Health Service Executive | Indication approved for reimbursement. |
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |