The U.S. Food and Drug Administration has granted Fast Track designation to AG-221 for the treatment of patients with acute myelogenous leukemia (AML) that harbors an isocitrate dydrogenase-2 mutation. AG-221 is a first-in-class, oral, selective, potent IDH2 mutant inhibitor.
The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.
This year, approximately 18,860 patients will be diagnosed with AML, and approximately 10,460 patients with AML will die, according to American Cancer Society statistics. A news release from the drug's manufacturer, Agios Pharmaceuticals, notes that approximately 20 percent of patients with AML have the IDH mutation and that
Phase I clinical trials for AG-221 are currently ongoing.