Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative status confers therapeutic sensitivity to Datopotamab deruxtecan in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration (FDA) granted approval to datopotamab deruxtecan-dlnk for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
This statement is based on a regulatory approval from the Food and Drug Administration:
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.