|Other names||DT388-IL3, SL-401, tagraxofusp-erzs|
|Drug class||Anti-cancer medication|
|Main uses||Blastic plasmacytoid dendritic cell neoplasm (BPDCN)|
|Side effects||Low albumin, liver problems, low platelets, nausea, tiredness, fever, capillary leak syndrome|
|Typical dose||12 ug/kg OD|
|Elimination half-life||51 minutes|
|Chemical and physical data|
|Molar mass||57695.30 g·mol−1|
Tagraxofusp, sold under the brand name Elzonris, is an anti-cancer medication used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN). It is given by gradual injection into a vein. Antihistamines and steroids are used to decrease t he risk of allergic reactions.
Common side effects include low albumin, liver problems, low platelets, nausea, tiredness, and fever. Other serious side effects may include capillary leak syndrome. Tagraxofusp is a fusion protein consisting of interleukin 3 (IL-3) fused to diphtheria toxin. The IL-3 attaches to BPDCN cells, resulting in their death.
Society and culture
In July 2020, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for tagraxofusp. 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. 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.
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). Tagraxofusp was approved for medical use in the European Union in January 2021.
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