FDA Approves Zolbetuximab-Clzb With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma
On October 18, 2024, the U.S. Food and Drug Administration (FDA) approved zolbetuximab-clzb (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.