Datroway (datopotamab deruxtecan-dlnk) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Daiichi Sankyo, Inc. Datroway (datopotamab deruxtecan-dlnk) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf. Revised January 2025. Accessed October 6, 2026.

Regulatory approvals

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

Indication	Statements
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Datopotamab deruxtecan
FDA (1)	HER2-negative, PR positive	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
FDA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Datopotamab deruxtecan