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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/05 | Phase 2 | Not yet recruiting | French Innovative Leukemia Organisation | ||
2024/08/19 | Phase 1 | Recruiting | |||
2024/07/12 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2024/06/13 | Phase 2 | Recruiting | |||
2024/05/16 | Early Phase 1 | Not yet recruiting | |||
2022/07/27 | Phase 1 | Recruiting | Therapeutic Advances in Childhood Leukemia Consortium | ||
2022/07/01 | Phase 2 | Recruiting | Joshua Zeidner | ||
2022/02/10 | Phase 1 | Recruiting | Karen Ballen, MD | ||
2021/09/09 | Phase 1 | Recruiting | |||
2021/09/02 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Stemline Therapeutics, Inc. | 72187-0401 | INTRAVENOUS | 1000 ug in 1 mL | 12/31/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/7/2021 | ||
Authorised | 1/7/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ELZONRIS CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MCG/ML | SIN17059P | INFUSION, SOLUTION CONCENTRATE | 1.0 MG/mL | 8/5/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||