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drugsProductApproved2018🇪🇺🇬🇧

Tagraxofusp

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

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).

Schematic of the modality · Recombinant cytotoxin (IL-3 fused to diphtheria toxin) · not a molecule; see the Monoclonal antibodies page
Mechanism, step by step
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1.IL-3 moiety binds CD123 on the blast

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).
Brand / code
Elzonris
Dosing & schedule
Route
IV over 15 minutes
Schedule
12 µg/kg daily on days 1-5 of a 21-day cycle; first cycle inpatient
Monitoring
Capillary leak syndrome (boxed warning): albumin, weight, oedema; hepatic enzymes

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. First cycle given inpatient for capillary leak syndrome monitoring (Part A).

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
EU-licensed 2021 for BPDCN; UK licence and NICE position not yet researched.

Sources: NICE search: tagraxofusp. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2018Blastic plasmacytoid dendritic cell neoplasm, adults and children ≥2

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Capillary leak syndrome
55%
9%
Hypoalbuminaemia
51%
Transaminase elevation
60%

Boxed warning. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Tagraxofusp
intervention: Tagraxofusp
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend26 papers in the last 12 months+37% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Tagraxofusp" OR ABSTRACT:"Tagraxofusp" OR TITLE:"Elzonris" OR ABSTRACT:"Elzonris") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tagraxofusp, not a curated reading list.

Connected

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