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 European Medicines Agency (EMA) has authorized tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have at least 2 prior anti-HER2 treatment regimens.
This statement is based on a regulatory approval from the European Medicines Agency:
TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.