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FDA Fast Track Designation Granted to AG-120 for Treatment of Patients With IDH1-Mutated Acute Myeloid Leukemia

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The U.S. Food and Drug Administration had granted Fast Track designation to AG-120 for the treatment of patients with acute myeloid leukemia who harbor an isocitrate dehydrogenase-1 (IDH1) mutation. Agios Pharmaceuticals’ AG-120 is a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein being evaluated in two phase I clinical trials, one in hematologic malignancies that recently initiated three expansion cohorts and one in advanced solid tumors, including glioma.

According to Chris Bowden, MD, Chief Medical Officer of Agios, data from an ongoing phase I study will be presented at the European Hematology Association 20th Annual Congress in June.

The FDA's Fast Track Drug Development Program is designed to expedite clinical development and submission of New Drug Applications (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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