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 an aromatase inhibitor as a treatment option for the treatment of HER2 positive, hormone-receptor positive metastatic breast cancer not previously treated with trastuzumab for patients who are postmenopausal. The corresponding European Medicines Agency (EMA) approval for this indication cites the clinical trial BO16216 as rationale for the approval where Herceptin (trastuzumab) and anastrozole were administered. 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 metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Reimbursement
Hospital
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | ER positive, HER2-positive, PR positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| HSE (1) | ER positive, HER2-positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| HSE (1) | ER positive, ERBB2 amplification, PR positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| HSE (1) | ER positive, ERBB2 amplification | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| HSE (1) | ERBB2 amplification, PR positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| HSE (1) | HER2-positive, PR positive | Invasive Breast Carcinoma | Anastrozole, 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 |
| 2019-09-21 | Health Service Executive | Indication approved for reimbursement. |