Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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