Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that ER positive and HER2-ultralow status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Invasive Breast Carcinoma.
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.
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.