Regulatory approval

Published by the Health Canada.

Health Canada approved trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received prior treatment with trastuzumab emtansine (T-DM1).

This is written in the approval document as:

ENHERTU (trastuzumab deruxtecan for injection) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received prior treatment with trastuzumab emtansine (T-DM1).

Citation

AstraZeneca Canada Inc. Enhertu (trastuzumab deruxtecan) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078361.PDF. Revised January 2025. 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 Trastuzumab deruxtecan