ELZONRIS
ELZONRIS (tagraxofusp-erzs) is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). This therapy is approved for use in both adult patients and pediatric patients aged 2 years and older. It serves as a targeted treatment option for patients diagnosed with this specific hematologic malignancy.
How ELZONRIS Works
Tagraxofusp-erzs is a fusion protein composed of recombinant human interleukin-3 (IL-3) and a truncated diphtheria toxin. The IL-3 component of the drug specifically targets and binds to the CD123 receptor on the surface of cells. Once the drug is internalized, it inhibits protein synthesis, which leads to cell death in CD123-expressing cells.
Details
- Status
- Prescription
- First Approved
- 2018-12-21
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
ELZONRIS Approval History
What ELZONRIS Treats
1 indicationsELZONRIS is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Blastic Plasmacytoid Dendritic Cell Neoplasm
ELZONRIS Boxed Warning
CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )...
WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELZONRIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full pr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.