Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved neoadjuvant chemotherapy followed by adjuvant trastuzumab for reimbursement as a treatment option for the treatment of HER2 positive early breast cancer for locally advanced (including inflammatory) disease or tumors > 2 cm in diameter. The corresponding European Medicines Agency (EMA) approval for this indication cites the multicenter randomized trial MO16432, which used doxorubicin in combination with paclitaxel for the neoadjuvant chemotherapy, in the rationale for this approval. The EMA product information for trastuzumab also 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 early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours >2cm in diameter.
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 | Doxorubicin, Paclitaxel, Trastuzumab | |
| HSE (1) | ERBB2 amplification | Invasive Breast Carcinoma | Doxorubicin, 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. |