Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regime.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	HER2-low, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	ER positive, HER2-low, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	ER positive, HER2-ultralow	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	HER2-ultralow, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	ER positive, HER2-ultralow, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan