Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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.
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.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Capecitabine, Trastuzumab, Tucatinib |