Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ERBB2 amplification status confers therapeutic sensitivity to Trastuzumab emtansine in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.