FDA Approves Astellas’ VYLOY for HER2-Negative Gastric and GEJ Adenocarcinoma

Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) for use in combination with fluoropyrimidine- and platinum-containing chemotherapy. This approval is for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with claudin (CLDN) 18.2 positive tumors, as determined by an FDA-approved test. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S. Publish Date: 21-10-2024 Source: Astellas Pharma Inc. Advanced or metastatic gastroesophageal junction adenocarcinoma, often referred to as GEJ adenocarcinoma, represents a particularly challenging and aggressive cancer subtype. This malignancy originates in the cells lining the junction between the stomach and the esophagus, known as the gastroesophageal junction (GEJ). The tumor’s epicenter is situated within the GEJ region in this...