Tagraxofusp

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Tagraxofusp
Names
Trade namesElzonris
Other namesDT388-IL3, SL-401, tagraxofusp-erzs
Clinical data
Drug classAnti-cancer medication[1]
Main usesBlastic plasmacytoid dendritic cell neoplasm (BPDCN)[1]
Side effectsLow albumin, liver problems, low platelets, nausea, tiredness, fever, capillary leak syndrome[2]
Routes of
use
Intravenous
Typical dose12 ug/kg OD[2]
External links
AHFS/Drugs.comMonograph
MedlinePlusa619022
Legal
License data
Legal status
Pharmacokinetics
MetabolismProteases (expected)
Elimination half-life51 minutes
Chemical and physical data
FormulaC2553H4026N692O798S16
Molar mass57695.30 g·mol−1

Tagraxofusp, sold under the brand name Elzonris, is an anti-cancer medication used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN).[1] It is given by gradual injection into a vein.[1] Antihistamines and steroids are used to decrease t he risk of allergic reactions.[2]

Common side effects include low albumin, liver problems, low platelets, nausea, tiredness, and fever.[2] Other serious side effects may include capillary leak syndrome.[2] Tagraxofusp is a fusion protein consisting of interleukin 3 (IL-3) fused to diphtheria toxin.[2] The IL-3 attaches to BPDCN cells, resulting in their death.[2]

Tagraxofusp was approved for medical use in the United States in 2018 and Europe in 2021.[1][2] In the United States it costs about 29,000 USD for 1000 ug as of 2021.[4]

Medical use

Dosage

It is given at a dose of 12 ug/kg per day.[2] It is given for 5 days in a row out of 21 days.[2]

History

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]

Society and culture

Legal status

In July 2020, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for tagraxofusp.[6] 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.[6] 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.[6]

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).[6] Tagraxofusp was approved for medical use in the European Union in January 2021.[2]

References

  1. 1.0 1.1 1.2 1.3 1.4 "Tagraxofusp-erzs Monograph for Professionals". Drugs.com. Retrieved 20 September 2021.
  2. 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 "Elzonris EPAR". European Medicines Agency (EMA). 21 July 2020. Retrieved 25 January 2021.
  3. "Elzonris- tagraxofusp injection, solution". DailyMed. 9 June 2020. Retrieved 21 September 2020.
  4. "Elzonris Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 20 September 2021.
  5. New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
  6. 6.0 6.1 6.2 6.3 "Elzonris: Pending EC decision". European Medicines Agency (EMA). 24 July 2020. Retrieved 21 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External links

External sites:
Identifiers: