TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY) on Thursday said the the U.S. Food and Drug Administration (FDA) granted Priority Review for the company's Biologics License Application (BLA) for zolbetuximab to treat gastric or gastroesophageal junction (GEJ) adenocarcinoma.
A decision from the FDA is expected on January 12, 2024.
If approved, zolbetuximab would be the first CLDN18.2 (Claudin 18.2)-targeted therapy available in the U.S. for patients with advanced gastric and gastroesophageal cancers, Astellas said.
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