Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
Roche announced that the VENTANA CLDN18 (43-14A) RxDx Assay is the first U.S. Food and Drug Administration (FDA) approved immunohistochemistry (IHC) companion diagnostic for determining CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOYTM (zolbetuximab).
Current guidelines for gastric/GEJ cancer recommend using biomarkers to guide therapeutic decision making. The new VENTANA CLDN18 (43-14A) RxDx Assay can help determine CLDN18.2 status and inform clinicians about the likelihood of patients benefiting from CLDN18.2 targeted therapy. VYLOY is the first FDA-approved treatment specifically targeting HER2-negative locally advanced unresectable or metastatic gastric or GEJ cancer patients whose tumours are CLDN18.2-positive.
