LUMAKRAS (sotorasib)
TherapyAmgen
LUMAKRAS (sotorasib) by Amgen is a targeted therapy for tumors carrying KRAS G12C mutations.
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 LUMAKRAS. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where LUMAKRAS is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | KRAS
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for LUMAKRAS.
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 LUMAKRAS for eligible patients.
Test
Guardant360 CDx
Guardant Health, Inc.
Method
NGS
Specimen
Plasma
1 approvalView test profile →
Test
therascreen KRAS RGQ PCR Kit
Qiagen Manchester, Ltd. (Qiagen)
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →