# Tagraxofusp

Source: https://onco.cc/drugs/tagraxofusp/  
OnCo record `tagraxofusp` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Tagraxofusp is a fusion of the growth factor IL-3 with a bacterial toxin that homes to CD123 on a rare, aggressive blood cancer.

## Summary

Approved 2018 for blastic plasmacytoid dendritic cell neoplasm (BPDCN), the first CD123-directed therapy (CR/CRc 57% in untreated patients). Capillary leak syndrome is the boxed warning. Under study in CD123+ AML and CMML, usually in combination. Now joined in BPDCN by the CD123 ADC pivekimab sunirine (2026).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Elzonris
- Modality: Recombinant cytotoxin (IL-3 fused to diphtheria toxin)
- Mechanism: IL-3 domain binds CD123 (IL-3Rα); internalised diphtheria toxin fragment inhibits protein synthesis (ADP-ribosylation of EF-2).
- Approvals: US 2018: Blastic plasmacytoid dendritic cell neoplasm, adults and children ≥2
- Dosing: IV over 15 minutes; 12 µg/kg daily on days 1-5 of a 21-day cycle; first cycle inpatient
- Toxicity (grade 3+): Capillary leak syndrome 9%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Tagraxofusp
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Tagraxofusp

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Blastic plasmacytoid dendritic cell neoplasm (BPDCN)](https://onco.cc/cancers/bpdcn/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [CD123](https://onco.cc/targets/cd123/)
- companies: [Menarini / Stemline](https://onco.cc/companies/menarini/)
- trials: [A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy](https://onco.cc/trials/nct06456463/)

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