VYLOY™

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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