Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) in combination with paclitaxel for reimbursement as a treatment option for the treatment of HER2 positive metastatic breast cancer in patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. The European Medicines Agency product information for trastuzumab notes that trastuzumab should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
This is written in the approval document as:
HER2 positive metastatic breast cancer (MBC) in combination with PACLitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
Reimbursement
Hospital
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | HER2-positive | Invasive Breast Carcinoma | Paclitaxel, Trastuzumab | |
| HSE (1) | ERBB2 amplification | Invasive Breast Carcinoma | Paclitaxel, Trastuzumab |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2026-08-02 | Van Allen lab | Initial curation of into moalmanac-db |
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |
| 2015-09-15 | Health Service Executive | Indication approved for reimbursement. |