Enhertu (trastuzumab deruxtecan) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 2
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). 1
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.
ENHERTU (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Trastuzumab deruxtecan
Sensitivity (+) HER2-low Invasive Breast Carcinoma Trastuzumab deruxtecan
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Trastuzumab deruxtecan
Sensitivity (+) HER2-positive Adenocarcinoma of the Gastroesophageal Junction Trastuzumab deruxtecan