TASIGNA (nilotinib)

TherapyNovartis

TASIGNA (nilotinib) from Novartis is a BCR-ABL1–targeting therapy used in chronic myeloid leukemia.

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 TASIGNA. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

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

Indication	Biomarker criteria	Notes
Chronic Myeloid Leukemia (CML) Heme · Leukemia	t(9;21) Philadelphia chromosome BCR-ABL fusion		View testing pathway →

Tumor-agnostic approvals

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

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 TASIGNA for eligible patients.

Test

MRDx BCR-ABL Test

MolecularMD Corporation

Method

PCR

Specimen

Whole blood

1 approvalView test profile →

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