Difference between revisions of "Ivosidenib (Tibsovo)"
Jump to navigation
Jump to search
(added package insert, links) |
|||
| Line 1: | Line 1: | ||
| − | == | + | ==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.tibsovo.com/pdf/prescribinginformation.pdf Ivosidenib (Tibsovo) package insert]</ref><ref>[[Media: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== | ||
*[[Acute_myeloid_leukemia,_IDH-mutated|IDH1-mutated AML]] | *[[Acute_myeloid_leukemia,_IDH-mutated|IDH1-mutated AML]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[https://www.tibsovo.com/pdf/prescribinginformation.pdf Ivosidenib (Tibsovo) package insert]<ref name="insert"></ref> | ||
| + | *[http://chemocare.com/chemotherapy/drug-info/ivosidenib.aspx Ivosidenib (Tibsovo) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/ivosidenib.aspx Ivosidenib (Tibsovo) patient drug information (Chemocare)]</ref> | ||
==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,_IDH-mutated|acute myeloid leukemia (AML) with a susceptible IDH1 mutation]] as detected by an FDA-approved test. | * 7/20/2018: Granted approval for adult patients with relapsed or refractory [[Acute_myeloid_leukemia,_IDH-mutated|acute myeloid leukemia (AML) with a susceptible IDH1 mutation]] as detected by an FDA-approved test. | ||
| − | * 5/2/2019: | + | * 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,_IDH-mutated|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)'' |
==Also known as== | ==Also known as== | ||
*'''Code name:''' AG-120 | *'''Code name:''' AG-120 | ||
*'''Brand name:''' Tibsovo | *'''Brand name:''' Tibsovo | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
Revision as of 21:25, 12 May 2019
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.
- 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)
Also known as
- Code name: AG-120
- Brand name: Tibsovo