VYLOY® (Zolbetuximab-clzb)

The FDA on October 18, 2024, approved VYLOY®, 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 (HER2)-negative Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test. VYLOY® is a product of Astellas Pharma US, Inc.