Difference between revisions of "Ivosidenib (Tibsovo)"
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===[[Acute myeloid leukemia]]=== | ===[[Acute myeloid leukemia]]=== | ||
* 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])'' | * 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] | + | * 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])'' |
| + | * 5/25/2022: Approved in combination with azacitidine 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 adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ''(Based on AG120-C-009)'' | ||
===[[Cholangiocarcinoma]]=== | ===[[Cholangiocarcinoma]]=== | ||
* 8/25/2021: Approved for adult patients with previously treated, locally advanced or metastatic [[cholangiocarcinoma]] with an [[Biomarkers#IDH1|isocitrate dehydrogenase-1 (IDH1)]] [[Biomarkers#Alterations|mutation]]. ''(Based on ClarIDHy)'' | * 8/25/2021: Approved for adult patients with previously treated, locally advanced or metastatic [[cholangiocarcinoma]] with an [[Biomarkers#IDH1|isocitrate dehydrogenase-1 (IDH1)]] [[Biomarkers#Alterations|mutation]]. ''(Based on ClarIDHy)'' | ||
Revision as of 19:21, 25 May 2022
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)
- 5/25/2022: 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 AG120-C-009)
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