Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized 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. 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:
Perjeta is indicated for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
Citation
Roche Registration GmbH. Perjeta (pertuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf. Revised December 2021. Accessed March 22, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Cyclophosphamide, Doxorubicin, Paclitaxel, Pertuzumab, Trastuzumab | |
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Docetaxel, Pertuzumab, Trastuzumab |