> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Priority Review for Tibsovo Supplemental NDA
- URL: https://www.fdaweb.com/priority-review-for-tibsovo-supplemental-nda/
- Published: 2022-03-07T12:00:00.000Z
- Updated: 2026-09-14T17:35:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151299

FDA has accepted for priority review a Servier supplemental NDA for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The submission is based on data from the AGILE study, a global Phase 3 trial in patients with previously untreated IDH1-mutated AML, which demonstrated that treatment with Tibsovo in combination with azacitidine significantly improved event-free survival, the company says. Additionally, the combination treatment reportedly showed a statistically significant improvement in overall survival.

Tibsovo is currently approved in the U.S. as monotherapy for treating adults with IDH1-mutant relapsed or refractory AML, and for adults with newly diagnosed IDH1-mutant AML who are aged 75 years and older or who have comorbidities that preclude the use of intensive induction chemotherapy. Recently, it was approved as a targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma.