KADCYLA (ado-trastuzumab emtansine)
TherapyGenentech
KADCYLA (ado-trastuzumab emtansine) from Genentech is an antibody-drug conjugate for HER2-positive breast cancer.
Approvals
5
Indications
1
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 KADCYLA. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where KADCYLA is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Breast Cancer Solid Tumor · Breast | ERBB2 (HER2)
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for KADCYLA.
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 KADCYLA for eligible patients.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
HER2 FISH pharmDx Kit
Dako Denmark A/S (Agilent Technologies, Inc.)
Method
FISH
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
HercepTest
Dako Denmark A/S (Agilent Technologies, Inc.)
Method
IHC
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
INFORM HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc. (Roche Diagnostics)
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 →