FDA Updates Gilteritinib AML Label With OS Data

May 30, 2019 – The FDA approved a supplemental new drug application (sNDA) to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory FLT3-mutant acute myeloid leukemia (AML). “The ADMIRAL trial’s overall survival findings are encouraging for patients and families impacted by … (leggi tutto)