Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

Citation

Seagen B.V. Tukysa (tucatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf. Revised August 2023. Accessed March 25, 2024.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-02-11	European Medicines Agency	Indication received approval from the European Commission.