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

Indications

Biomarkers

Mapped tests

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
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung	ERBB2 (HER2) Activating Mutations (SNVs And Exon 20 Insertions)		View testing pathway →
Breast Cancer Solid Tumor · Breast	ERBB2 (HER2) HER2-low expression (IHC 1+ or IHC 2+/ISH non-amplified)		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

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 →

Test

PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc. (Roche Diagnostics)

Method

IHC

Specimen

Tissue (FFPE)

2 approvalsView test profile →

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