ZIIHERA (zanidatamab-hrii)
TherapyJazz Pharmaceuticals
ZIIHERA (zanidatamab-hrii) from Jazz Pharmaceuticals is a HER2-targeted bispecific antibody used in HER2-expressing solid tumors.
Approvals
1
Indications
1
Biomarkers
1
Mapped tests
1
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and ZIIHERA. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ZIIHERA is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Biliary Tract Cancer Solid Tumor · Biliary | ERBB2 (HER2)
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ZIIHERA.
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 ZIIHERA for eligible patients.
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 →