GLEEVEC (imatinib mesylate)
TherapyNovartis
GLEEVEC (imatinib mesylate) from Novartis is a precision therapy used in cancers driven by BCR-ABL, KIT, or PDGFRA alterations.
Approvals
3
Indications
3
Biomarkers
3
Mapped tests
3
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and GLEEVEC. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where GLEEVEC is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Aggressive Systemic Mastocytosis Heme · Mastocytosis | KIT
| View testing pathway → | |
Myelodysplastic Syndromes (MDS) Heme · Bone Marrow | PDGFRB
| View testing pathway → | |
Gastrointestinal Stromal Tumors (GIST) Solid Tumor · GIST | C-Kit
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for GLEEVEC.
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 GLEEVEC for eligible patients.
Test
KIT D816V Assay
ARUP Laboratories, Inc.
Method
PCR
Specimen
Bone marrow
1 approvalView test profile →
Test
PDGFRB FISH Assay
ARUP Laboratories, Inc.
Method
FISH
Specimen
Bone marrow
1 approvalView test profile →
Test
Dako c-KIT pharmDx
Dako North America, Inc. (Agilent Technologies, Inc.)
1 approvalView test profile →