Difference between revisions of "Ivosidenib (Tibsovo)"
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==Patient drug information== | ==Patient drug information== | ||
*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf Ivosidenib (Tibsovo) package insert]<ref name="insert"></ref> | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf Ivosidenib (Tibsovo) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/ivosidenib.aspx Ivosidenib (Tibsovo) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ivosidenib.aspx Ivosidenib (Tibsovo) patient drug information (Chemocare)]</ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
Revision as of 23:31, 2 September 2023
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 established
Patient drug information
History of changes in FDA indication
Acute myeloid leukemia
- 2018-07-20: 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)
- 2019-05-02: 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)
- 2022-05-25: Approved in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (Based on AGILE)
Cholangiocarcinoma
- 2021-08-25: 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