MedPath

Tagraxofusp

Generic Name
Tagraxofusp
Brand Names
Elzonris
Drug Type
Biotech
CAS Number
2055491-00-2
Unique Ingredient Identifier
8ZHS5657EH

Overview

Tagraxofusp is a CD123-directed cytotoxin. It is a fusion protein composed of a human interleukin-3 (IL-3) that is genetically fused to the catalytic and translocation domains of truncated diphtheria toxin (DT) produced in Escherichia coli. Tagraxofusp received its first global approval by the FDA on December 21, 2018 as the first FDA-approved treatment for blastic plasmacytoid dendritic cell neoplasm, which is a myeloid malignancy in the dendritic cell lineage. It was also approved by the European Commission on January 7, 2021.

Background

Tagraxofusp is a CD123-directed cytotoxin. It is a fusion protein composed of a human interleukin-3 (IL-3) that is genetically fused to the catalytic and translocation domains of truncated diphtheria toxin (DT) produced in Escherichia coli. Tagraxofusp received its first global approval by the FDA on December 21, 2018 as the first FDA-approved treatment for blastic plasmacytoid dendritic cell neoplasm, which is a myeloid malignancy in the dendritic cell lineage. It was also approved by the European Commission on January 7, 2021.

Indication

Tagraxofusp is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). In the US, it is approved for use in adults and pediatric patients over 2 years old. In Europe, it is only approved for use in adults.

Associated Conditions

  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

FDA Approved Products

Elzonris
Manufacturer:Stemline Therapeutics, Inc.
Route:INTRAVENOUS
Strength:1000 ug in 1 mL
Approved: 2018/12/31
NDC:72187-0401

Singapore Approved Products

ELZONRIS CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MCG/ML
Manufacturer:Alcami Carolinas Corporation
Form:INFUSION, SOLUTION CONCENTRATE
Strength:1.0 MG/mL
Online:Yes
Approved: 2024/08/05
Approval:SIN17059P

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