VYLOY (zolbetuximab)

TherapyAstellas Pharma

VYLOY (zolbetuximab) from Astellas Pharma is a targeted therapy for CLDN18.2-positive gastric and GEJ cancers.

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 VYLOY. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where VYLOY is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria	Notes
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Solid Tumor · Stomach/GEJ	Claudin 18 (CLDN18) Claudin 18 (CLDN18) protein expression (≥75% viable tumor cells (% TC) staining)		View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for VYLOY.

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 VYLOY for eligible patients.

Test

Ventana CLDN18 (43-14A) RxDx Assay

Ventana Medical Systems, Inc. (Roche Diagnostics)

Method

IHC

Specimen

Tissue (FFPE)

1 approvalView test profile →

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