Difference between revisions of "Ivosidenib (Tibsovo)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Acute myeloid leukemia]]=== | ===[[Acute myeloid leukemia]]=== | ||
| − | * 2018-07-20: 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/study/NCT02074839 | + | * 2018-07-20: 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/study/NCT02074839 NCT02074839] AG120-C-001])'' |
| − | * 2019-05-02: [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/study/NCT02074839 | + | * 2019-05-02: [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/study/NCT02074839 NCT02074839] AG120-C-001])'' |
* 2022-05-25: 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 AGILE)'' | * 2022-05-25: 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 AGILE)'' | ||
===[[Cholangiocarcinoma]]=== | ===[[Cholangiocarcinoma]]=== | ||
Revision as of 11:38, 4 July 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 NCT02074839 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 NCT02074839 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