OPDIVO (nivolumab)
TherapyBristol Myers Squibb
OPDIVO (nivolumab) from Bristol Myers Squibb is a PD-1 immunotherapy used across multiple solid tumors.
Approvals
2
Indications
1
Biomarkers
8
Mapped tests
2
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and OPDIVO. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where OPDIVO is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Colorectal Cancer (CRC) Solid Tumor · Colorectal | ACVR2A
| View testing pathway → | |
Colorectal Cancer (CRC) Solid Tumor · Colorectal | deficient mismatch repair (dMMR) proteins
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for OPDIVO.
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 OPDIVO for eligible patients.
Test
Idylla CDx MSI Test
Biocartis US Inc.
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
MMR IHC Panel pharmDx
Dako Omnis (Agilent Technologies, Inc.)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →