Flumatinib (Xinfu)

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General information

From the NCI Drug Dictionary: The orally bioavailable, mesylate salt form of the tyrosine kinase inhibitor flumatinib, with potential antineoplastic activity. Upon administration, flumatinib inhibits the wild-type forms of Bcr-Abl, platelet-derived growth factor receptor (PDGFR) and mast/stem cell growth factor receptor (SCFR; c-Kit) and forms of these proteins with certain point mutations. This results in the inhibition of both Bcr-Abl-, PDGFR- and c-Kit-mediated signal transduction pathways, and the proliferation of tumor cells in which these kinases are overexpressed.

Diseases for which it is used

  1. FESTnd: Zhang L, Meng L, Liu B, Zhang Y, Zhu H, Cui J, Sun A, Hu Y, Jin J, Jiang H, Zhang X, Li Y, Liu L, Zhang W, Liu X, Gu J, Qiao J, Ouyang G, Liu X, Luo J, Jiang M, Xie X, Li J, Zhao C, Zhang M, Yang T, Wang J. Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study. Clin Cancer Res. 2021 Jan 1;27(1):70-77. Epub 2020 Sep 14. link to original article PubMed NCT02204644

History of changes in NMPA approval

  • 2019-11-25: Initial approval for the treatment of adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (Ph+CML) in the chronic phase.

Also known as

  • Code name: HH-GV-678
  • Generic name: flumatinib mesylate
  • Brand name: Xinfu