Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. According to the EMA product information for this indication, this indication is based on BERENICE (WO29217), a nonrandomized, open-label, multicenter, multinational, phase 2 clinical study where the treatment regimes were either (i) doxoruicin and cyclophosphamide followed by pertuzumab in combination with trastuzumab and paclitaxel or (ii) pertuzumab in combination with trastuzumab and docetaxel.
This is written in the approval document as:
Pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
Reimbursement
Hybrid
Pertuzumab - ODMS 2020-07-01; Trastuzumab, Chemotherapy - 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 | Docetaxel, Pertuzumab, Trastuzumab | |
| HSE (1) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |
| 2020-07-01 | Health Service Executive | Indication approved for reimbursement. |