Therapeutic Response

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

Statements

Source and description
Enhertu (trastuzumab deruxtecan) [product information]. EMA. The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimes.
Enhertu (trastuzumab deruxtecan) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either (i) in the metastatic setting, or (ii) in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.