Regulatory approval

Published by the Food and Drug Administration. Accelerated

DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

This is written in the approval document.

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 (1)	EGFR Somatic variants	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
FDA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
FDA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
FDA (1)	EGFR p.T790M	Non-Small Cell Lung Cancer	Datopotamab deruxtecan
FDA (1)	EGFR Exon 20 (Insertion)	Invasive Breast Carcinoma	Datopotamab deruxtecan