Tibsovo (ivosidenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf. Revised May 2022. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. 10

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) IDH1 p.R132C Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132G Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132H Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132L Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132S Acute Myeloid Leukemia Ivosidenib
FDA (1) IDH1 p.R132C Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132G Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132H Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132L Acute Myeloid Leukemia Azacitidine, Ivosidenib
FDA (1) IDH1 p.R132S Acute Myeloid Leukemia Azacitidine, Ivosidenib