FDA Grants Quizartinib Breakthrough Designation for FLT3-ITD+ AML

August 1, 2018 – The FDA has granted a breakthrough therapy designation to quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia (AML), according to Daiichi Sankyo, the manufacturer of the FLT3 inhibitor. The designation, which will expedite the development and review of quizartinib in this setting, is based on findings from the phase III QuANTUM-R study, in which the FLT3 inhibitor reduced the risk of disease … (leggi tutto)