Posted by Michael Wonder on 26 Nov 2016
Arog Pharmaceuticals receives FDA fast track designation for crenolanib for advanced gastro-intestinal stromal tumours with a D842V mutation in the PDGFRA gene
16 November 2016 - Arog Pharmaceuticals, today announced that the U.S. FDA has granted fast track designation for crenolanib for the treatment of patients with unresectable or metastatic gastro-intestinal stromal tumours harbouring a platelet-derived growth factor receptor alpha (PDGFRα) D842V mutation.
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. The company is currently recruiting patients for a Phase 3 multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with unresectable or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally 3 times dail in combination with best supportive care.
