Therapeutic Response

HER2-low status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Invasive Breast Carcinoma.

Statements

Source and description
Enhertu (trastuzumab deruxtecan) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to trastuzumab deruxtecan for the treatment of of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Enhertu (trastuzumab deruxtecan) [product monograph]. HC. Health Canada approved trastuzumab deruxtecan as a monotherapy 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.