HERCEPTIN (trastuzumab)
TherapyGenentech
HERCEPTIN (trastuzumab) from Genentech is a HER2-directed monoclonal antibody widely used in HER2-positive breast and gastric cancers.
Approvals
14
Indications
2
Biomarkers
1
Mapped tests
12
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and HERCEPTIN. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where HERCEPTIN is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Breast Cancer Solid Tumor · Breast | ERBB2 (HER2)
| View testing pathway → | |
Gastric and Gastroesophageal Cancer Solid Tumor · Stomach/GEJ | ERBB2 (HER2)
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for HERCEPTIN.
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 HERCEPTIN for eligible patients.
Test
Bond Oracle HER2 IHC System
Leica Biosystems
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
HER2 CISH pharmDx Kit
Dako Denmark A/S (Agilent Technologies, Inc.)
1 approvalView test profile →
Test
HER2 FISH pharmDx Kit
Dako Denmark A/S (Agilent Technologies, Inc.)
Method
FISH
Specimen
Tissue (FFPE)
2 approvalsView test profile →
Test
HercepTest
Dako Denmark A/S (Agilent Technologies, Inc.)
Method
IHC
Specimen
Tissue (FFPE)
2 approvalsView test profile →
Test
INFORM HER-2/neu
Ventana Medical Systems, Inc. (Roche Diagnostics)
1 approvalView test profile →
Test
InSite Her-2/neu (CB11) Monoclonal Antibody
Biogenex Laboratories, Inc.
1 approvalView test profile →
Test
INFORM HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc. (Roche Diagnostics)
1 approvalView test profile →
Test
PathVysion HER-2 DNA Probe Kit
Abbott Molecular, Inc.
Method
FISH
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. (Roche Diagnostics)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
SPOT-LIGHT HER2 CISH Kit
Life Technologies Corporation (ThermoFisher Scientific)
1 approvalView 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 →