18 October 2024 - Today, the FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma), a claudin 18.2 (CLDN18.2) directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are CLDN18.2 positive, as determined by an FDA approved test.

Today, FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic device to identify patients with gastric or gastro-oesophageal junction adenocarcinoma who may be eligible for treatment with zolbetuximab.

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