XALKORI (crizotinib)
TherapyPfizer
XALKORI (crizotinib) from Pfizer is a targeted therapy used in ALK-positive or ROS1-positive lung cancer.
Approvals
4
Indications
1
Biomarkers
2
Mapped tests
4
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and XALKORI. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where XALKORI is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | ALK
| View testing pathway → | |
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | ROS1
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for XALKORI.
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 XALKORI for eligible patients.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
Oncomine Dx Target Test
Life Technologies Corporation (ThermoFisher Scientific)
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
Ventana ALK (D5F3) CDx Assay
Ventana Medical Systems, Inc. (Roche Diagnostics)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
Vysis ALK Break Apart FISH Probe Kit
Abbott Molecular, Inc.
Method
FISH
Specimen
Tissue (FFPE)
1 approvalView test profile →