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 | + | * 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: 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== | ||
Revision as of 00:37, 3 May 2019
Mechanism of action
From the NCI Drug Dictionary: An orally available inhibitor of isocitrate dehydrogenase type 1 (IDH1), with potential antineoplastic activity. Upon administration, ivosidenib specifically inhibits a mutated form of IDH1 in the cytoplasm, which inhibits the formation of the oncometabolite, 2-hydroxyglutarate (2HG). This may lead to both an induction of cellular differentiation and an inhibition of cellular proliferation in IDH1-expressing tumor cells.
Diseases for which it is used
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: 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