Enhertu (trastuzumab deruxtecan) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
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.	1
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.	2
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.	2
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.	6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	HER2-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	ERBB2 oncogenic variants	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan
Sensitivity (+)	ERBB2 amplification	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan
Sensitivity (+)	HER2-positive	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab deruxtecan
Sensitivity (+)	ERBB2 amplification	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab deruxtecan
Sensitivity (+)	EGFR somatic variants	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
Sensitivity (+)	EGFR p.T790M	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
Sensitivity (+)	EGFR Exon 20 (Insertion)	Invasive Breast Carcinoma	Datopotamab deruxtecan
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Datopotamab deruxtecan