Tibsovo (ivosidenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. Accessed October 30, 2024.

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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
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory AML. 5
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes. 5
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated. 5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (2) IDH1 p.R132C Acute Myeloid Leukemia Ivosidenib
FDA (2) IDH1 p.R132G Acute Myeloid Leukemia Ivosidenib
FDA (2) IDH1 p.R132H Acute Myeloid Leukemia Ivosidenib
FDA (2) IDH1 p.R132L Acute Myeloid Leukemia Ivosidenib
FDA (2) 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
FDA (1) IDH1 p.R132C Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132G Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132H Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132L Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132S Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132C Cholangiocarcinoma Ivosidenib
FDA (1) IDH1 p.R132G Cholangiocarcinoma Ivosidenib
FDA (1) IDH1 p.R132H Cholangiocarcinoma Ivosidenib
FDA (1) IDH1 p.R132L Cholangiocarcinoma Ivosidenib
FDA (1) IDH1 p.R132S Cholangiocarcinoma Ivosidenib