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FDA Approves Astellas’ VYLOY for Advanced Gastric & GEJ Cancer

The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Astellas Pharma Inc.’s 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. VYLOY is the first and only CLD...

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