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.

Citation

Seagen Inc. Tukysa (tucatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf. Revised January 2023. Accessed October 30, 2024. Seagen Inc. Tukysa (tucatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213411s000lbl.pdf. Revised April 2020. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2020-04-17	Food and Drug Administration	Indication received traditional approval.