Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) for reimbursement as a monotherapy treatment option for the treatment of HER2 positive metastatic breast cancer (MBC) in patients who have received at least two chemotherapy regimens for their metastatic disease. The indication further notes that prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. 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) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
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 | Trastuzumab | |
| HSE (1) | ERBB2 amplification | Invasive Breast Carcinoma | 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. |