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Ref Type
PMID
Authors
Title Elzonris (tagraxofusp-erzs) FDA Drug Label
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Vol
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URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761116
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Tagraxofusp-erzs Elzonris Tagraxofusp|SL-401|DT3881L3|DT-3881L3 Elzonris (Tagraxofusp-erzs) is a fusion protein consists of human interleukin 3 (IL3) and the first 388 amino acids of diphtheria toxin [DT(388)], which binds to IL3 receptors and subsequently inhibits protein synthesis, leading to cell death (PMID: 28479592). Elzonris (tagraxofusp-erzs) is FDA approved for use in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown aggressive NK-cell leukemia not applicable Tagraxofusp-erzs FDA approved Actionable In a Phase I/II trial that supported FDA approval, Elzonris (tagraxofusp-erzs) treatment resulted in complete response/clinical complete response in 53.8% (7/13) of patients with untreated blastic plasmacytoid dendritic cell neoplasm (BPDCN, also known as natural killer cell leukemia/lymphoma) with a median follow-up of 11.5 months, and 1 complete response and 1 clinical complete response in 15 patients with relapsed or refractory BPDCN (FDA.gov; NCT02113982). detail... detail...