Astellas Vylox, Roche Ventana CDx approved for gastric cancer
Oct. 22, 2024—The FDA has approved zolbetuximab-clzb (Vyloy, Astellas Pharma), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.