Difference between revisions of "Ivosidenib (Tibsovo)"
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==General information== | ==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.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf Ivosidenib (Tibsovo) package insert]</ref><ref>[[ | + | 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.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf Ivosidenib (Tibsovo) package insert]</ref><ref>[[File:Ivosidenib.pdf | Ivosidenib (Tibsovo) package insert (locally hosted backup)]]</ref><ref>[https://www.tibsovo.com/ Tibsovo manufacturer's website]</ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
Revision as of 00:04, 20 September 2021
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.[1][2][3]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
Acute myeloid leukemia
- 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. (Based on AG120-C-001)
- 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; based on AG120-C-001)
Cholangiocarcinoma
- 8/25/2021: Approved for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation. (Based on ClarIDHy)
Also known as
- Code name: AG-120
- Brand name: Tibsovo