Astellas Secures FDA Approval for Pioneering CLDN18.2 Gastric Cancer Therapy VYLOY

The FDA has granted approval to Astellas for VYLOY (zolbetuximab), making it the first anti-CLDN18.2 drug approved in the U.S. for advanced gastric cancer. This pioneering therapy is designated for first-line treatment of adults with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, when combined with specific chemotherapy regimens. This decision was primarily based on positive outcomes from the SPOTLIGHT and GLOW Phase 3 trials, which demonstrated significant improvements in both progression-free survival and overall survival. An FDA-approved test, the Roche VENTANA CLDN18 assay, is necessary to confirm CLDN18.2 positivity before treatment[1][2].