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FDA Approval Sought for Ivosidenib in IDH1+ AML

Silas Inman @silasinman
Published: Tuesday, Dec 26, 2017

Dr. Chris Bowden

Chris Bowden, MD
A new drug application (NDA) has been submitted for ivosidenib (AG-120) for patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

The phase III AGILE trial is evaluating the combination of ivosidenib plus azacitidine compared with placebo and azacitidine for untreated patients with IDH1-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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