Agios Announces FDA Fast Track Designation Granted to AG-120 for Treatment of Patients with Acute Myelogenous Leukemia with an IDH1 Mutation

Agios Pharmaceuticals, Inc.

, a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation. AG-120 is a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein being evaluated in two Phase 1 clinical trials, one in hematologic malignancies that recently initiated three expansion cohorts, and one in advanced solid tumors, including glioma. "We are pleased that now both AG-120 and AG-221 have been granted Fast Track designation, demonstrating the FDA's commitment to facilitate the development and expedite the review of our lead IDH programs as important new therapies for people with AML who carry these mutations," said Chris Bowden, M.D., chief medical officer of Agios. "We look forward to presenting new data from the ongoing Phase 1 study at the EHA Annual Congress next month and remain on track to initiate a global, registration-enabling Phase 3 study in collaboration with Celgene in AML patients who harbor an IDH1 mutation in the first half of 2016." 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. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available.