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 trastuzumab emtansine as a monotherapy for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy. The FDA product label states to select patients for therapy based on an FDA-approved companion diagnostic for Kadcyla.
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 (ado-trastuzumab emtansine) [product monograph]. HC.

Health Canada approved trastuzumab emtansine for the treatment of HER2-positive metastatic breast cancer patients who received both prior treatment with trastuzumab and a taxane, separately or in combination.
Kadcyla (ado-trastuzumab emtansine) [product monograph]. HC.

Health Canada approved trastuzumab emtansine for the adjuvant treatment of HER2-positive early breast cancer patients who have residual invasive disease following neoadjuvant taxane and trastuzumab-based treatment.