Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. For the purposes of this indication, HER2-low is defined as a score of IHC 1+ or IHC 2+/ISH-, as assessed by a CE-marked IVD medical device or alternative valid 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-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

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-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-01-23	European Medicines Agency	Indication received approval from the European Commission.