LORBRENA (lorlatinib)
TherapyPfizer
LORBRENA (lorlatinib) from Pfizer is a kinase inhibitor used in ALK-positive lung cancer.
Approvals
1
Indications
1
Biomarkers
1
Mapped tests
1
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and LORBRENA. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where LORBRENA 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 → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for LORBRENA.
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 LORBRENA for eligible patients.
Test
Ventana ALK (D5F3) CDx Assay
Ventana Medical Systems, Inc. (Roche Diagnostics)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →