Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Capecitabine, Trastuzumab, Tucatinib in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration granted approval to tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
This statement is based on a regulatory approval from the Food and Drug Administration:
TUKYSA is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.