ENHERTU (fam-trastuzumab deruxtecan-nxki)
TherapyDaiichi Sankyo, AstraZeneca
ENHERTU (fam-trastuzumab deruxtecan-nxki) by Daiichi Sankyo and AstraZeneca is an antibody-drug conjugate for HER2-expressing or HER2-low tumors.
Approvals
7
Indications
2
Biomarkers
1
Mapped tests
5
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and ENHERTU. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ENHERTU is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Breast Cancer Solid Tumor · Breast | ERBB2 (HER2)
| View testing pathway → | |
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | ERBB2 (HER2)
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ENHERTU.
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 ENHERTU for eligible patients.
Test
PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. (Roche Diagnostics)
Method
IHC
Specimen
Tissue (FFPE)
3 approvalsView test profile →
Test
Ventana HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc. (Roche Diagnostics)
Method
ISH
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
Guardant360® Liquid CDx
Guardant Health, Inc.
Method
NGS
Specimen
Whole blood
1 approvalView test profile →
Test
Guardant360 CDx
Guardant Health, Inc.
Method
NGS
Specimen
Plasma
1 approvalView test profile →
Test
Oncomine Dx Target Test
Life Technologies Corporation (ThermoFisher Scientific)
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →