Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) HER2-positive Invasive Breast Carcinoma Capecitabine, Trastuzumab, Tucatinib