TIBSOVO(ivosidenib, CS3010, AG-120)

Ivosidenib is an investigational first-in-class, orally available, selective, potent inhibitor of the mutated IDH1 protein and is a highly targeted investigational medicine for the treatment of patients with cancers that harbor an IDH1 mutation. IDH1 is a metabolic enzyme that is mutated in a wide range of cancers, including acute myeloid leukemia, cholangiocarcinoma and glioma. Ivosidenib is currently under U.S. FDA priority review for IDH1m R/R AML patients with a PDUFA action date of August 21, 2018. The following clinical trials of ivosidenib are ongoing:

  • Phase 1 trial of ivosidenib or enasidenib in combination with 7+3 in patients with newly diagnosed IDHm AML who are eligible for standard-of-care chemotherapy

  • Phase 3 AGILE trial of ivosidenib in combination with azacitidine in patients with newly diagnosed IDH1m AML who are not eligible for standard-of-care chemotherapy

  • Phase 3 ClarIDHy trial of ivosidenib in advanced IDH1m cholangiocarcinoma

Perioperative study comparing ivosidenib and AG-881 in IDH1m low-grade glioma

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