General AML,   FLT3

FDA grants Orphan Drug Designation to CG’806 for the treatment of AML

Last month, the US Food and Drug Administration (FDA) granted Orphan Drug Designation to CG’806, a multi-kinase inhibitor, for the treatment of patients with Acute Myeloid Leukemia (AML).

CG’806 is a highly potent, first-in-class, oral inhibitor of FMS like Tyrosine Kinase 3 (FLT3)/ Bruton’s Tyrosine Kinase (BTK). Preclinical studies have demonstrated that, CG’806 can inhibit AML harbouring FLT3- Internal Tandem Duplication (FLT3-ITD), Tyrosine Kinase Domain (TKD) mutations or both by inhibiting FLT3/BTK/Aurora Kinase (AuroK) activation.  Additionally, CG’806 exhibits a profound suppression of cell proliferation in FLT3-mutant AML cells.

Aptose Biosciences, the drug manufacturers, noted that based on the encouraging preclinical data of CG’806, they are eager to begin clinical trials in AML later this year.

  1. GlobeNewswire: FDA Grants Orphan Drug Designation to Aptose Biosciences for CG’806 in Acute Myeloid Leukemia. 2017 December 26. [Accessed 2018 Jan 4].
  2. Yu. G. et al. CG '806, a Novel Pan-FLT3/BTK Multi-Kinase Inhibitor, Induces Cell Cycle Arrest, Apoptosis or Autophagy in AML Cells Depending on FLT3 Mutation Status. Blood. 2017 130: 4629.
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