Ivosidenib (Tibsovo)

General information

Class/mechanism: IDH1 inhibitor. Ivosidenib inhibits the mutant isocitrate dehydrogenase 1 (IDH1) enzyme at lower drug concentrations than wild-type IDH1. Inhibiting mutant IDH1 enzyme prevents formation of the oncometabolite 2-hydroxyglutarate (2HG) in leukemia cells, causes a reduction in IDH1-expressing tumor cells, and increases percentages of mature myeloid cells.

Diseases for which it is used

• IDH1-mutated AML

Patient drug information

• Ivosidenib (Tibsovo) package insert
• Ivosidenib (Tibsovo) patient drug information (Chemocare)

History of changes in FDA indication

• 7/20/2018: Granted approval for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
• 5/2/2019: FDA approval expanded "for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy." (approval expanded to first-line setting with limitations)

Also known as

• Code name: AG-120
• Brand name: Tibsovo