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TIBSOVO (ivosidenib)

TherapyServier Pharmaceuticals

TIBSOVO (ivosidenib) from Servier is a targeted therapy for IDH1-mutant AML and cholangiocarcinoma.

Approvals

Indications

Biomarkers

Mapped tests

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and TIBSOVO. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where TIBSOVO is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria
Acute Myeloid Leukemia (AML) Heme · Leukemia	IDH1 R132 mutations (R132C, R132H, R132G, R132S, and R132L)	View testing pathway →
Myelodysplastic Syndromes (MDS) Heme · Bone Marrow	IDH1 R132 mutations (R132C, R132H, R132G, R132S, and R132L)	View testing pathway →
Cholangiocarcinoma Solid Tumor · Bile Duct	IDH1 Single nucleotide variants	View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for TIBSOVO.

No tumor-agnostic companion diagnostic approvals are currently mapped for this therapy.

Tests used in these approvals

These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering TIBSOVO for eligible patients.

Test

Abbott RealTime IDH1

Abbott Molecular, Inc.

Method

PCR

Specimen

Whole blood

2 approvalsView test profile →

Test

Oncomine Dx Target Test

Life Technologies Corporation (ThermoFisher Scientific)

Method

NGS

Specimen

Tissue (FFPE)

1 approvalView test profile →

This view is scoped to TIBSOVO (ivosidenib). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.