Regulatory approval

Published by the Health Canada. Approved

ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options.

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
HC (1) HER2-positive Any solid tumor Trastuzumab deruxtecan

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals