FDA Grants Priority Review to Gilteritinib for FLT3+ AML

May 29, 2018 – The FDA has granted a priority review to a new drug application (NDA) 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 AML. Data from … (leggi tutto)