Regulatory approval

Published by the European Medicines Agency. Approved

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.

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)	ER positive, HER2-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan
EMA (1)	HER2-low, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
EMA (1)	ER positive, HER2-low, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
EMA (1)	ER positive, HER2-ultralow	Invasive Breast Carcinoma	Trastuzumab deruxtecan
EMA (1)	HER2-ultralow, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
EMA (1)	ER positive, HER2-ultralow, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2025-08-29	Van Allen lab	On 2025-04-28, the EMA published an EPAR - Assessment report - Variation that added an extension indication to trastuzumab deruxtecan for the treatment of patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting.
2025-03-31	European Medicines Agency	Indication received approval from the European Commission.