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

Regulatory approval published by the Food and Drug Administration.

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.

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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 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. 5
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.

Type Biomarker(s) Cancer type Therapy(ies)
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
Sensitivity (+) HER2-negative, PR positive Non-Small Cell Lung Cancer Datopotamab deruxtecan
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Datopotamab deruxtecan