Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.