Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ERBB2 amplification status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have an activating HER2 (ERBB2) variant and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

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 advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

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 July 2026. Accessed August 2, 2026.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-10-18	European Medicines Agency	Indication received approval from the European Commission.