Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of patients with HER2-overexpressing breast cancer. The product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for herceptin.
This statement is based on a regulatory approval from the Food and Drug Administration:
Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2 -overexpressing breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.