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news.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.
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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.
"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," Bowden said.
"We are committed to working with our partner Celgene Corporation to get this medicine to patients as soon as possible."
AML, which is a cancer of blood and bone marrow characterized by rapid disease progression, is the most common acute leukemia affecting adults.
The company discovers and develops new drugs for the treatment of cancer and rare genetic disorders of metabolism through scientific leadership in the field of cellular metabolism.