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FDA BLA · BLA761139

ENHERTU

fam-trastuzumab deruxtecan-nxki

Sponsor: DAIICHI SANKYO

APPLICATION
BLA761139
TYPE
BLA
ORIGINAL APPROVAL
2019-12-20
LATEST ACTION
2026-05-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ENHERTUPrescription
FAM-TRASTUZUMAB DERUXTECAN-NXKI 100MG · INJECTABLE · INJECTION

Approval history

2026-05-15Efficacy · Supplement 43 · priority — Letter ↗AP
2026-05-15Efficacy · Supplement 41 · standard — Letter ↗AP
2026-04-27Efficacy · Supplement 39 · standard — Label ↗AP
2025-12-15Labeling · Supplement 42 · standard — Label ↗AP
2025-12-15Efficacy · Supplement 38 · priority — Label ↗AP
2025-01-27Efficacy · Supplement 32 · priority — Label ↗AP
2025-01-27Labeling · Supplement 35 · standard — Label ↗AP
2024-04-05Efficacy · Supplement 28 · priority — Label ↗AP
2024-02-15Efficacy · Supplement 26 · standard — Label ↗AP
2022-11-04Efficacy · Supplement 24 · priority — Label ↗AP
2022-08-11Efficacy · Supplement 21 · priority — Label ↗AP
2022-08-05Efficacy · Supplement 22 · priority — Letter ↗AP
2022-05-04Efficacy · Supplement 20 · priority — Label ↗AP
2022-05-04Efficacy · Supplement 17 · priority — Label ↗AP
2021-01-15Efficacy · Supplement 11 · priority — Label ↗AP
2019-12-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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