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Molecular Profile IDH1 mutant
Therapy Azacitidine + 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 Azacitidine + Ivosidenib FDA approved - Has Companion Diagnostic Actionable In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248). detail... 35443108 detail...
IDH1 mutant acute myeloid leukemia sensitive Azacitidine + Ivosidenib Guideline Actionable Tibsovo (ivosidenib) in combination with Vidaza (azacitidine) is included in guidelines for patients with relapsed or refractory acute myeloid leukemia harboring an IDH1 mutation (NCCN.org). detail...
PubMed Id Reference Title Details
NCCN.org Full reference...
Full reference...
Tibsovo (ivosidenib) FDA Drug Label Full reference...
(35443108) Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. Full reference...