Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved lapatinib in combination with capecitabine for reimbursement as a treatment option for the treatment of adult patients with advanced or metastatic breast cancer whose tumors overexpress HER2 with disease progression following prior therapy, which should have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. The European Medicine Agency product information sheet for lapatinib defines HER2 (ErbB2) overexpressing tumors as IHC3+, or IHC2+ with gene amplification or gene amplification alone.
This is written in the approval document as:
Treatment of adult patients with breast cancer, whose tumours overexpress HER2 in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which should have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.
Reimbursement
CDS
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 | Capecitabine, Lapatinib | |
| HSE (1) | ERBB2 amplification | Invasive Breast Carcinoma | Capecitabine, Lapatinib |
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 |
| 2015-01-10 | Health Service Executive | Indication approved for reimbursement. |