Regulatory approval

Published by the European Medicines Agency.

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 April 2025. Accessed August 29, 2025.

Therapeutic response

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

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	ERBB2 oncogenic variants	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan
EMA (1)	ERBB2 amplification	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan