Regulatory approval

Published by the Health Canada.

Health Canada approved trastuzumab deruxtecan 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 as:

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.

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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) HER2-positive Any solid tumor Trastuzumab deruxtecan