Therapeutic Response

HER2-positive 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 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.
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. The product information further specifies that patients treated with trastuzumab deruxtecan for breast cancer should have documented HER2 positive tumor status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of >= 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.