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FDA grants fast track designation to AG-221 for IDH2-mutant AML
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The FDA granted fast track designation to AG-221 as a potential treatment for patients with acute myelogenous leukemia who harbor IDH2 genetic mutations, the drug’s manufacturer announced.
AG-221 (Agios Pharmaceuticals) is an oral, selective, potent IDH2-mutant inhibitor.
Chris Bowden
“We believe this designation is an important recognition by the FDA of the nonclinical and clinical data reported to date and the potential for AG-221 to address a significant unmet need for patients diagnosed with AML,” Chris Bowden, MD, chief medical officer of Agios, said in a press release. “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 Corporation to get this medicine to patients as soon as possible.”
The FDA based its decision on preliminary data from a phase 1 trial designed to assess clinical activity and tolerability of AG-221 in 22 patients with advanced hematologic malignancies with an IDH2 mutation. Patients received AG-221 in one of four doses: 30 mg twice daily, 50 mg twice daily, 75 mg twice daily or 100 mg once daily.