LIBTAYO (cemiplimab-rwlc)
TherapyRegeneron
LIBTAYO (cemiplimab-rwlc) by Regeneron is a PD-1 inhibitor used in multiple solid tumors, including advanced skin cancers.
Approvals
2
Indications
1
Biomarkers
1
Mapped tests
2
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and LIBTAYO. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where LIBTAYO is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | PD-L1
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for LIBTAYO.
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 LIBTAYO for eligible patients.
Test
PD-L1 IHC 22C3 pharmDx
Dako North America, Inc. (Agilent Technologies, Inc.)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
Ventana PD-L1 (SP263) Assay
Ventana Medical Systems, Inc. (Roche Diagnostics)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →