The US Food and Drug Administration (FDA) has granted Fast Track designation to Agios Pharmaceuticals’ AG-221, a first-in-class, oral, selective, potent IDH2 mutant inhibitor, to treat patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.

Currently, AG-221 is being evaluated in a Phase I clinical trial in patients with advanced hematologic malignancies. Agios chief medical officer Dr Chris Bowden said the company believes 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.

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