Therapeutic Response

HER2-positive status confers therapeutic sensitivity to Trastuzumab emtansine in patients with Invasive Breast Carcinoma.

Statements

Source and description
Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine.
Kadcyla (ado-trastuzumab emtansine) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for ado-trastuzumab emtansine.
Kadcyla (trastuzumab emtansine) [product information]. EMA.

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.
Kadcyla (trastuzumab emtansine) [product information]. EMA.

The European Medicines Agency (EMA) has authorized trastuzumab emtansine for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in cobmination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.