VYLOY™

Published on October 18, 2024

FDA Approves Vyloy for the Treatment of Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

  • Gastric and gastroesophageal junction (G/GEJ) cancer is the fifth most commonly diagnosed cancer worldwide.
  • Vyloy is the first and only CLDN18.2-targeted therapy approved in the U.S.

Source: Astellas Pharma US, Inc.

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