Regulatory approval

Published by the Health Canada.

Health Canada approved tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.

This is written in the approval document as:

TUKYSA (tucatinib) is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.

Citation

Seagen Inc. Tukysa (tucatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00062119.PDF. Revised July 2021. Accessed June 2025.

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