Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration (FDA) granted approval to datopotamab deruxtecan-dlnk 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.

This is written in the approval document as:

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.

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/2025/761464s000lbl.pdf. Revised June 2025. Accessed September 2, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Datopotamab deruxtecan
FDA (2)	HER2-negative, PR positive	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Datopotamab deruxtecan

Contributions

Date	Contributor	Description
2025-09-02	Van Allen lab	The US FDA approved datopotamab deruxtecan for the treatment of adult patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
2025-01-17	Food and Drug Administration	Indication received traditional approval.