The FDA has approved zolbetuximab-clzb, in combination with chemotherapy, for first-line treatment of adults with locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2-positive. The approval is based on the Phase 3 SPOTLIGHT and GLOW clinical trials, where the drug showed promising results. Zolbetuximab-clzb is a claudin 18.2-targeting monoclonal antibody that can be used alongside fluoropyrimidine- and platinum-based chemotherapy.
It works by depleting CLDN18.2-positive cancer cells through antibody-dependent cellular and complement-dependent cytotoxicity. Clinical Trials SPOTLIGHT Phase 3 SPOTLIGHT is a global, multi-center, double-blind, randomized Phase 3 study evaluating the efficacy and safety of zolbetuximab combined with mFOLFOX6 (a chemotherapy regimen containing oxaliplatin, leucovorin, and fluorouracil) versus…
