Posted by Michael Wonder on 11 Oct 2017
U.S. FDA grants fast track designation to Astellas for development of gilteritinib in relapsed or refractory acute myeloid leukaemia
10 October 2017 - Astellas announced today that the U.S. FDA has granted fast track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukaemia.
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication as well as FLT3 tyrosine kinase domain, two common types of FLT3 mutations that are seen in approximately one-third of patients with acute myeloid leukaemia (AML).
Astellas is currently investigating gilteritinib in various AML patient populations through four ongoing Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ AML.
