FDA Approval Sought for Gilteritinib in FLT3+ AML

April 24, 2018 – A new drug application (NDA) has been filed with the FDA for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML), according to Astellas Pharma, the manufacturer of the FLT3 inhibitor. The NDA is based on data from the ongoing phase III ADMIRAL study, which is comparing gilteritinib with salvage chemotherapy in adult patients with FLT3-positive relapse/refractory … (leggi tutto)