Clinical data | |
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Pronunciation | /təɡˈræksəfʌsp/ təg-RAKS-ə-fusp |
Trade names | Elzonris |
Other names | DT388-IL3, SL-401, tagraxofusp-erzs |
AHFS/Drugs.com | Monograph |
MedlinePlus | a619022 |
License data |
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Routes of administration | Intravenous |
ATC code | |
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Pharmacokinetic data | |
Metabolism | Proteases (expected) |
Elimination half-life | 51 minutes |
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Chemical and physical data | |
Formula | C2553H4026N692O798S16 |
Molar mass | 57695.30 g·mol−1 |
Tagraxofusp, sold under the brand name Elzonris, is an anti-cancer medication for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). [4] [5]
Tagraxofusp is a fusion protein consisting of interleukin 3 (IL-3) fused to diphtheria toxin. [6] [1] The fusion protein readily kills cultured pDC by binding to their IL-3 receptors to thereby gain entrance to the cells and then blocking these cells' protein synthesis (due to its diphtheria toxin portion inhibiting eukaryotic elongation factor 2).[ medical citation needed ]
It was approved for use in the United States in 2018, [7] and in the European Union in January 2021. [2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]
In July 2020, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for tagraxofusp. [9] The Agency was concerned that due to the design of the study and the small number of participants, it was not possible to be sure how effective the medicine was in treating blastic plasmacytoid dendritic cell neoplasm. [9] In addition, the medicine could cause capillary leak syndrome (an unpredictable, potentially life-threatening side effect due to increased permeability of small blood vessels), which had led to some fatal outcomes. [9]
On 12 November 2020, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for the medicinal product Elzonris, intended for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). [9] Tagraxofusp was approved for medical use in the European Union in January 2021. [2]
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Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare hematologic malignancy. It was initially regarded as a form of lymphocyte-derived cutaneous lymphoma and alternatively named CD4+CD56+ hematodermic tumor, blastic NK cell lymphoma, and agranular CD4+ NK cell leukemia. Later, however, the disease was determined to be a malignancy of plasmacytoid dendritic cells rather than lymphocytes and therefore termed blastic plasmacytoid dendritic cell neoplasm. In 2016, the World Health Organization designated BPDCN to be in its own separate category within the myeloid class of neoplasms. It is estimated that BPDCN constitutes 0.44% of all hematological malignancies.
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