Astellas Gains FDA Nod for First CLDN18.2 Gastric Cancer Drug Vyloy

Astellas Pharma Inc. has achieved a significant milestone with the FDA approval of Vyloy (zolbetuximab), the first anti-CLDN18.2 drug for advanced gastric cancer available in the U.S. This approval is specifically for the first-line treatment of adults with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, to be used alongside specific chemotherapy agents[1][2]. The decision is underpinned by the successful SPOTLIGHT and GLOW phase 3 trials, which indicated improvements in progression-free and overall survival for patients[1][2]. Despite initial manufacturing delays, Vyloy's approval was finalized following adjustments in its review timeline, revealing Astellas' commitment to addressing unmet medical needs with pioneering therapies[1].