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Molecular Profile | IDH1 R132C |
Therapy | Ivosidenib |
Indication/Tumor Type | acute myeloid leukemia |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
IDH1 R132C | acute myeloid leukemia | sensitive | Ivosidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial that supported FDA approval, Tibsovo (ivosidenib) treatment resulted in complete remission (CR) in 28.6% (8/28), CR with partial hematological recovery (CRh) in 14.3% (4/28) of patients age 75 or older with untreated acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) as detected by an FDA-approved test, with a median treatment duration of 4.3 months (PMID: 29860938; NCT02074839). | detail... 29860938 detail... |
IDH1 R132C | acute myeloid leukemia | sensitive | Ivosidenib | FDA approved - On 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... detail... 29860938 |
PubMed Id | Reference Title | Details |
---|---|---|
Ivosidenib (AG-120) in Mutant IDH1 AML and Advanced Hematologic Malignancies: Results of a Phase 1 Dose Escalation and Expansion Study | Full reference... | |
(29860938) | Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. | Full reference... |
(29860938) | Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. | Full reference... |
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Tibsovo (ivosidenib) FDA Drug Label | Full reference... | |
Tibsovo (ivosidenib) FDA Drug Label | Full reference... |