Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab deruxtecan (Enhertu) for reimbursement as a monotherapy treatment option for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
This is written in the approval document as:
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Reimbursement
ODMS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | HER2-low | Invasive Breast Carcinoma | Trastuzumab deruxtecan |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-07-01 | Health Service Executive | Indication approved for reimbursement. |
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |