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.
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 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.