Regulatory approval

Published by the European Medicines Agency. Approved

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 is written in the approval document as:

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ERBB2 activating variants	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan
EMA (1)	ERBB2 amplification	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan

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.