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FDA Grants Priority Review to Ivosidenib for IDH1+ AML

Silas Inman @silasinman
Published: Thursday, Feb 15, 2018

Dr David Schenkein

David Schenkein, MD
The FDA has granted a priority review designation to ivosidenib (AG-120) for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

-mutant AML (NCT03173248). Additionally, an expanded access program is currently available for those with relapsed/refractory AML with an IDH1 mutation (NCT03245424).
DiNardo CD, De Botton S, Stein EM, et al. Ivosidenib (AG-120) in Mutant IDH1 AML and Advanced Hematologic Malignancies: Results of a Phase 1 Dose Escalation and Expansion Study. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta, Georgia. Abstract 725.

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