Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that EGFR somatic variants status confers therapeutic sensitivity to Datopotamab deruxtecan in patients with Non-Small Cell Lung Cancer.

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.

Citation

Daiichi Sankyo Europe GmbH. Enhertu (trastuzumab deruxtecan) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf. Revised April 2025. Accessed August 29, 2025.