Datopotamab Deruxtecan · Datroway, DS-1062

What is Datopotamab Deruxtecan?

Datopotamab deruxtecan is a Trop-2-directed antibody-drug conjugate comprising a humanized anti-Trop-2 IgG1 linked to the topoisomerase I inhibitor DXd. After binding Trop-2 on tumor cells and internalization, DXd is released and causes DNA damage and apoptosis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Datroway, DS-1062, DS-1062A, Dato-DXd

Drug type

Antibody-drug conjugate

Targets

Trop-2 (TACSTD2), DNA topoisomerase I (secondary target)

Mechanism

Cytotoxic, directed at Trop-2 (TACSTD2)

Pathways

DNA damage, apoptosis

Therapy area

Oncology

Developer

Daiichi Sankyo Inc

In trials of

AZN, SMMT

FDA status

Approved as Datroway (January 17, 2025), BLA761394 · FDA label

UNII

GD2OWY1DTK

✅ FDA-approved uses

• Locally advanced or metastatic EGFR-mutated non-small cell lung cancer
• Unresectable or metastatic triple-negative breast cancer
• Unresectable or metastatic HR-positive, HER2-negative breast cancer

From the indications section of the FDA label (version of May 27, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Breast CancerNon-Small Cell Lung Cancer

Other drugs acting on TACSTD2

Sources

• FDA Purple Book
• FDA label (DailyMed)
• FDA label Datroway (2026-05-27), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT06103864
• ClinicalTrials.gov NCT07535437

Updated Oct 3, 2026.