Difference between revisions of "Ivosidenib (Tibsovo)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 7/20/2018: Granted approval for adult patients with relapsed or refractory [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. | + | * 7/20/2018: Granted approval for adult patients with relapsed or refractory [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. ''(Based on [https://clinicaltrials.gov/ct2/show/NCT02074839 AG120-C-001])'' |
| − | * 5/2/2019: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-first-line-treatment-aml-idh1-mutation FDA approval expanded] "for newly-diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|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)'' | + | * 5/2/2019: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-first-line-treatment-aml-idh1-mutation FDA approval expanded] "for newly-diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|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 [https://clinicaltrials.gov/ct2/show/NCT02074839 AG120-C-001])'' |
==Also known as== | ==Also known as== | ||
Revision as of 14:06, 20 April 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
- 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)
Also known as
- Code name: AG-120
- Brand name: Tibsovo