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 (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. The product information further specifies that patients treated with trastuzumab emtansine should have HER2 positive tumor status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of >= 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.
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. The product information further specifies that patients treated with trastuzumab emtansine should have HER2 positive tumor status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of >= 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.
Trastuzumab Emtansine (Kadcyla) - 21 days. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved 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 combination. Patients should have either (i) received prior therapy for locally advanced or metastatic disease or (ii) developed disease recurrence during or within six months of completing adjuvant therapy.
Trastuzumab Emtansine (Kadcyla) Early Breast Cancer Therapy - 21 days. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab emtansine as a single agent for reimbursement as a treatment option 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.