Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab in patients with Gastrointestinal Stromal Tumor.
The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab.
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 metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.