Posted by Michael Wonder on 01 Apr 2020
MEI Pharma announces fast track designation granted by U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma
31 March 2020 - MEI Pharma today announced that the U.S. FDA granted fast track designation to ME-401, MEI's investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta for the treatment of adult Patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin's Lymphoma), a Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.
