Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer [Yahoo! Finance]
ASTELLAS PHARMA UNSP/ADR (ALPMY)
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Source: Yahoo! Finance
adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura , "Astellas") today 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. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S. In the SPOTLIGHT and GLOW clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive. CLDN18.2 positivity is defined as =75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohi
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