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# FDA Accepts Agios Pharma NDA for Ivosidenib
- URL: https://www.fdaweb.com/fda-accepts-agios-pharma-nda-for-ivosidenib/
- Published: 2018-02-15T12:00:00.000Z
- Updated: 2026-09-14T23:22:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140775

FDA has accepted for review an Agios Pharmaceuticals NDA for ivosidenib (AG-120) for treating patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation. The submission was granted a priority review, with a user fee review action date of 8/21\. Ivosidenib is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 1.

The submission is based on data from AG120-C-001, a Phase 1 dose-escalation and expansion study of ivosidenib in patients with advanced hematologic malignancies and the mutation. Additionally, the company’s partner, Abbott, has submitted a PMA for an assay to identify the mutation on its m2000 RealTime System, an automated sample preparation and batch analyzer system for nucleic acid amplification and detection.