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# Priority Review for Servier’s Tibsovo sNDA
- URL: https://www.fdaweb.com/priority-review-for-serviers-tibsovo-snda/
- Published: 2023-08-16T12:00:00.000Z
- Updated: 2026-09-14T18:50:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155116

FDA has accepted a Servier sNDA and will give priority review for Tibsovo (ivosidenib) to treat IDH1-mutated relapsed or refractory myelodysplastic syndromes (MDS). A company [statement](https://servier.us/blog/servier-announces-fda-filing-acceptance-and-priority-review-for-tibsovo-ivosidenib-tablets-in-the-treatment-of-idh1-mutated-relapsed-or-refractory-r-r-myelodysplastic-syndromes-mds/?ref=fdaweb.com) says that if the indication is approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within the molecularly defined subset.

Tibsovo is FDA-approved as monotherapy to treat adults with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML) or in combination with azacitidine (Bristol Myers Squibb’s Vidaza, Onureg) for adults with newly diagnosed IDH1-mutated AML who are at least 75 years old or who have comorbidities that preclude the use of intensive induction therapy.