The FDA has approved Astellas Pharma's zolbetuximab-clzb (Vyloy) in combination with chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The approval is based on results from two clinical trials, SPOTLIGHT and GLOW, which showed improved progression-free and overall survival with zolbetuximab-clzb plus chemotherapy compared to chemotherapy alone. The FDA also approved the VENTANA CLDN18 RxDx Assay as a companion diagnostic.
Zolbetuximab-clzb is administered intravenously, starting with a dose of 800 mg/m2, followed by maintenance doses every two or three weeks. Common adverse reactions include nausea, vomiting, and neutropenia. The approval applies specifically to patients whose tumors are CLDN18.2 positive, identified through an FDA-approved diagnostic test.
The drug received priority review, fast track, and orphan drug designations.
