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IMAGE: Daniel A. Pollyea, MD, MS and colleagues report clinical trial results leading to FDA approval of ivosidenib against IDH1+ AML. view more 

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Clinical trials at University of Colorado Cancer Center and elsewhere now result in the drug ivosidenib earning approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Ivosidenib, an oral, targeted inhibitor of the IDH1 enzyme, is the first and only FDA-approved therapy for patients with R/R AML and an IDH1 mutation.

“Ivosidenib is an important new weapon in the arsenal,” says Daniel A. Pollyea, MD, MS, investigator at CU Cancer Center, clinical director of Leukemia Services at the CU School of Medicine, and principal investigator of early ivosidenib trials. “It’s a very well tolerated oral therapy for patients who have few options and it is an important new tool for us to use.”

AML is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases estimated in the U.S. each year. The majority of patients with AML eventually

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