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. The FDA also approved the Roche Ventana CLDN18 (43-14A) RxDx assay as a companion diagnostic to identify patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with Vyloy.
Efficacy was evaluated in the randomized, double-blind, multicenter SPOTLIGHT and GLOW trials that enrolled patients with CLDN18.2 positive advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma. The major efficacy outcome measure in both trials was progression-free survival, as assessed per RECIST v1.1 by an independent review committee.