Posted by Michael Wonder on 02 Dec 2017
Arog Pharmaceuticals receives FDA fast track designation for crenolanib in relapsed or refractory FLT3-positive AML
1 December 2017 - Arog Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for crenolanib for the treatment of patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.
Crenolanib is an orally bioavailable benzimidazole type I kinase inhibitor that selectively and potently inhibits signaling of wild-type and mutant isoforms of class III receptor tyrosine kinases FLT3 and PDGFRα/β. Crenolanib can be safely administered at maximal doses in combination with 7+3 induction and high dose cytarabine (HiDAC) consolidation. The company is preparing for a Phase 3 multicenter, randomised, double-blinded, placebo-controlled, trial of oral crenolanib versus placebo in combination with best supportive care in subjects with FLT3 mutation-positive relapsed or refractory acute myeloid leukaemia.
