Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Paclitaxel, Trastuzumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized trastuzumab in combination with paclitaxel for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) that have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. The production information for trastuzumab 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 statement is based on a regulatory approval from the European Medicines Agency:
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.