Agios Pharma: FDA Grants Fast Track Designation To AG-221 - Quick Facts

(RTTNews) - Agios Pharmaceuticals, Inc. (AGIO) announced the U.S. FDA has granted Fast Track designation to AG-221 for the treatment of patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.

AG-221 is a first-in-class, oral, selective, potent IDH2 mutant inhibitor being evaluated in a Phase 1 clinical trial in patients with advanced hematologic malignancies.

The company said it remains 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 the current year.