Gilteritinib

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.[6] It acts as an inhibitor of AXL receptor tyrosine kinase, hence it is a tyrosine kinase inhibitor.[7]

Gilteritinib
Clinical data
Trade namesXospata
AHFS/Drugs.comMonograph
MedlinePlusa619003
License data
Pregnancy
category
  • AU: D [1]
  • US: N (Not classified yet) [2]
    Routes of
    administration    		By mouth
    ATC code
    Legal status
    Legal status
    • AU: S4 (Prescription only) [1]
    • UK: POM (Prescription only) [3]
    • US: ℞-only [4]
    • EU: Rx-only [5]
    • In general: ℞ (Prescription only)
    Identifiers
    CAS Number
    PubChem CID
    DrugBank
    ChemSpider
    UNII
    KEGG
    ChEBI
    Chemical and physical data
    FormulaC29H44N8O3
    Molar mass552.724 g·mol−1
    3D model (JSmol)

    It was developed by Astellas Pharma.

    In April 2018, Astellas filed a new drug application with the Food and Drug Administration for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).[8]

    In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.[9][4]

    Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients.[10]

    Gilteritinib has been repurposed as a potential antiviral drug as a possible application in the treatment of COVID-19.[11]

    References
    1. "Xospata Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 11 April 2020. Retrieved 16 August 2020.
    2. "Gilteritinib (Xospata) Use During Pregnancy". Drugs.com. 20 August 2019. Retrieved 16 August 2020.
    3. "Xospata 40 mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 13 November 2019. Retrieved 16 August 2020.
    4. "Xospata- gilteritinib tablet". DailyMed. 31 May 2019. Retrieved 16 August 2020.
    5. "Xospata EPAR". European Medicines Agency (EMA). 16 September 2019. Retrieved 16 August 2020.
    6. Perl AE, Altman JK, Cortes J, Smith C, Litzow M, Baer MR, et al. (August 2017). "Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1-2 study". The Lancet. Oncology. 18 (8): 1061–1075. doi:10.1016/S1470-2045(17)30416-3. PMC 5572576. PMID 28645776.
    7. Lee LY, Hernandez D, Rajkhowa T, Smith SC, Raman JR, Nguyen B, et al. (January 2017). "Preclinical studies of gilteritinib, a next-generation FLT3 inhibitor". Blood. 129 (2): 257–260. doi:10.1182/blood-2016-10-745133. PMC 5234222. PMID 27908881.
    8. "FDA Approval Sought for Gilteritinib in FLT3+ AML". onclive.com. April 24, 2018. Retrieved September 29, 2018.
    9. "FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation". U.S. Food and Drug Administration (FDA). 2018-11-28. Retrieved 2018-11-29.
    10. "U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)". Drugs.com. Retrieved 2018-12-03.
    11. Bouhaddou M, Memon D, Meyer B, White KM, Rezelj VV, et al. (2020-08-06). "The Global Phosphorylation Landscape of SARS-CoV-2 Infection". Cell. 182: 1–28. doi:10.1016/j.cell.2020.06.034. Retrieved 2020-07-24.
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