Treats newly diagnosed AML. NDA 211192, held by Servier. Ivosidenib.
As of Nov 14, 2026, NDA 211192 (Tibsovo), held by Servier, was first approved by FDA on Jul 20, 2018, with 6 approved supplements and 0 published complete response letters.
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Relapsed or refractory AML For the treatment of adult patients with relapsed or refractory AML. Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.
| Oct 24, 2023 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| May 25, 2022 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Aug 25, 2021 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| May 2, 2019 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jul 20, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tibsovo250MG · tablet;oral | Ivosidenib | RxReference drug |
| Oct 24, 2023 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| May 25, 2022 | Supplement 9Efficacy (new indication or use) · Priority review | Approved | |
| Aug 25, 2021 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Mar 18, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Mar 17, 2020 | Supplement 2Labeling · Standard review | Approved | |
| May 2, 2019 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jul 20, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
