Regulatory approval

Published by the Health Canada. Approved

ENHERTU (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

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
Organizations Biomarkers Cancer types Therapies

Contributions

Date Contributor Description