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# Agios Pharma sNDA for Tibsovo Approved
- URL: https://www.fdaweb.com/agios-pharma-snda-for-tibsovo-approved/
- Published: 2019-05-02T12:00:00.000Z
- Updated: 2026-09-15T01:24:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144018

FDA has approved an Agios Pharmaceuticals supplemental NDA to update the U.S. prescribing information for Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are 75 years and older or who have comorbidities that preclude use of intensive induction chemotherapy. Tibsovo received initial FDA approval 7/2018 for treating adult patients with relapsed or refractory AML.