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KADCYLA (ado-trastuzumab emtansine)

TherapyGenentech

KADCYLA (ado-trastuzumab emtansine) from Genentech is an antibody-drug conjugate for HER2-positive breast cancer.

Approvals

Indications

Biomarkers

Mapped tests

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) gene amplification		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 →

This view is scoped to KADCYLA (ado-trastuzumab emtansine). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.