FDA grants CG-806 investigational new drug allowance for the treatment of AML

On June 29, 2020, the U.S. Food and Drug Administration (FDA) granted approval of an investigational new drug application for the initiation of a phase Ia/b study on CG-806 for the treatment of patients with acute myeloid leukemia.

CG-806 is an oral FLT3/BTK inhibitor. It demonstrates potent inhibition of wild type and FLT3 mutant forms as well as non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme in murine leukemia models. CG-806 is under investigation in patients with B-cell malignancies, including chronic lymphocytic leukemia and non-Hodgkin lymphomas, who are resistant/refractory or intolerant to current therapies.

The FDA has allowed the initiation of a clinical trial in patients with relapsed/refractory acute myeloid leukemia at a starting dose of 450 mg, twice a day. The phase Ia/b study will start in the second half of 2020.