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-approved 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 information]. EMA. The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. For the purposes of this indication, HER2-low is defined as a score of IHC 1+ or IHC 2+/ISH-, as assessed by a CE-marked IVD medical device or alternative valid test.