FDA Grants Quizartinib Priority Review for FLT3-ITD+ AML

November 22, 2018 – The FDA has granted a priority review designation to a new drug application (NDA) for 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 priority designation, which follows a breakthrough therapy designation, is based on findings from the phase III QuANTUM-R study. Results from the trial … (leggi tutto)