Profile Response Detail


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Molecular Profile IDH1 mutant
Therapy Ivosidenib
Indication/Tumor Type acute myeloid leukemia
Response Type sensitive


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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 mutant acute myeloid leukemia sensitive Ivosidenib Guideline Actionable Tibsovo (ivosidenib) is included in guidelines for patients with relapsed or refractory acute myeloid leukemia harboring an IDH1 mutation ( detail...
IDH1 mutant acute myeloid leukemia sensitive Ivosidenib FDA approved - Has Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 21.6% (27/125), CR with partial hematological recovery (CRh) in 8.8% (11/125), and overall response (OR) in 41.6% (52/125) of patients with relapsed or refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test (PMID: 29860938; NCT02074839). detail... detail... 29860938
PubMed Id Reference Title Details Full reference...
(29860938) Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. Full reference...
Full reference...
Tibsovo (ivosidenib) FDA Drug Label Full reference...