Therapeutic Response

ER positive and HER2-low 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 as a monotherapy for the treatment of adult patients with metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
Enhertu (trastuzumab deruxtecan) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to fam-trastuzumab deruxtecan-nxki, as monotherapy, for the treatment of adult patients with unresectable or metastatic hormone receptor-positive HER2-low (immunohistochemistry 1+ or immunohistochemistry 2+/in situ hybridization-negative) or HER2-ultralow (immunohistochemistry 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting. This indication is based on DESTINY-Breast06, in which HER2-ultralow was defined as membrane staining that was seen in greater than 0 and less than or equal to 10% of tumor cells.