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 unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimes. The product information further specifies that patients treated with trastuzumab deruxtecan for breast cancer should have documented HER2 positive tumor status, defined as a score of 3+ by immunohistochemistry (IHC) or a ratio of >= 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.

This is written in the approval document as:

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

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	Invasive Breast Carcinoma	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-07-11	European Medicines Agency	Indication received approval from the European Commission.