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.

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.	15
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.
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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	IDH1 p.R132C	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132C	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132G	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132G	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132H	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132H	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132L	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132L	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132S	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132S	Acute Myeloid Leukemia	Ivosidenib
Sensitivity (+)	IDH1 p.R132C	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
Sensitivity (+)	IDH1 p.R132G	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
Sensitivity (+)	IDH1 p.R132H	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
Sensitivity (+)	IDH1 p.R132L	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
Sensitivity (+)	IDH1 p.R132S	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
Sensitivity (+)	IDH1 p.R132C	Myelodysplastic Syndromes	Ivosidenib
Sensitivity (+)	IDH1 p.R132G	Myelodysplastic Syndromes	Ivosidenib
Sensitivity (+)	IDH1 p.R132H	Myelodysplastic Syndromes	Ivosidenib
Sensitivity (+)	IDH1 p.R132L	Myelodysplastic Syndromes	Ivosidenib
Sensitivity (+)	IDH1 p.R132S	Myelodysplastic Syndromes	Ivosidenib
Sensitivity (+)	IDH1 p.R132C	Cholangiocarcinoma	Ivosidenib
Sensitivity (+)	IDH1 p.R132G	Cholangiocarcinoma	Ivosidenib
Sensitivity (+)	IDH1 p.R132H	Cholangiocarcinoma	Ivosidenib
Sensitivity (+)	IDH1 p.R132L	Cholangiocarcinoma	Ivosidenib
Sensitivity (+)	IDH1 p.R132S	Cholangiocarcinoma	Ivosidenib