ALECENSA (alectinib)
TherapyGenentech
ALECENSA (alectinib) is a targeted therapy from Genentech used in tumors driven by specific ALK alterations.
Approvals
3
Indications
1
Biomarkers
1
Mapped tests
3
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and ALECENSA. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ALECENSA 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 ALECENSA.
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 ALECENSA for eligible patients.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood
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 →