ERBITUX (cetuximab)
TherapyEli Lilly
ERBITUX (cetuximab) from Eli Lilly is an EGFR-directed monoclonal antibody used in biomarker-defined colorectal and head-and-neck cancers.
Approvals
7
Indications
1
Biomarkers
2
Mapped tests
6
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and ERBITUX. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ERBITUX is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Colorectal Cancer (CRC) Solid Tumor · Colorectal | KRAS
| View testing pathway → | |
Colorectal Cancer (CRC) Solid Tumor · Colorectal | EGFR (HER1)
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ERBITUX.
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 ERBITUX for eligible patients.
Test
cobas KRAS Mutation Test
Roche Molecular Systems, Inc. (Roche Diagnostics)
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
Dako EGFR pharmDx Kit
Dako North America, Inc. (Agilent Technologies, Inc.)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Pillar Biosciences, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
therascreen KRAS RGQ PCR Kit
Qiagen Manchester, Ltd. (Qiagen)
Method
PCR
Specimen
Tissue (FFPE)
2 approvalsView test profile →
Test
xT CDx
Tempus
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →