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FDA BLA · BLA761394

DATROWAY

datopotamab deruxtecan

Sponsor: DAIICHI SANKYO INC

APPLICATION
BLA761394
TYPE
BLA
ORIGINAL APPROVAL
2025-01-17
LATEST ACTION
2026-05-22
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DATROWAYPrescription
DATOPOTAMAB DERUXTECAN-DLNK 100MG · INJECTABLE · IV (INFUSION)

Approval history

2026-05-22Efficacy · Supplement 3 · priorityLetterAP
2025-01-17Type 1 - New Molecular Entity · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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