Regulatory approval

Published by the European Medicines Agency. Approved

Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

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)	HER2-positive	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab deruxtecan
EMA (1)	ERBB2 amplification	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-12-12	European Medicines Agency	Indication received approval from the European Commission.