Agios gets Fast Track designation for AML candidate
CAMBRIDGE, Mass.—Agios Pharmaceuticals Inc. has announced that AG-221 has received Fast Track designation from the U.S. Food and Drug Administration for the treatments of acute myelogenous leukemia (AML) in patients with an isocitrate dehydrogenase-2 (IDH2) mutation. The compound is a first-in-class, oral, selective, potent IDH2 mutant inhibitor under evaluation in a Phase 1 clinical trial in individuals with advanced hematologic malignancies. AML affects some 115,000 to 160,000 patients worldwide, 20 percent of whom present with an IDH mutation.
Dr. Chris Bowden, chief medical officer of Agios, said that “We remain on track to initiate the planned expansion cohorts for patients with IDH2 mutant-positive AML and other IDH2 mutant-positive hematologic malignancies in the second half of this year. We are committed to working with our partner Celgene Corp. to get this medicine to patients as soon as possible.”