U.S. License Holder:
Astellas
Date of License:
October-18-2024
Last Update:
Dec-15-2024
FDA-Approved Indications
VYLOY (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody and is indicated in combination 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 adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.