Regulatory approval

Published by the Health Canada. Approved

ENHERTU (trastuzumab deruxtecan for injection) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy.

This is written in the approval document.

Citation

AstraZeneca Canada Inc. Enhertu (trastuzumab deruxtecan) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082205.PDF. Revised October 2025. Accessed April 2026.

Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HC (1) HER2-positive Invasive Breast Carcinoma Trastuzumab deruxtecan
HC (1) HER2-low Invasive Breast Carcinoma Trastuzumab deruxtecan