/PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA).
FDA Accepts BLA Resubmission for Zolbetuximab in CLDN18.2+ Advanced Gastric/GEJ Adenocarcinoma onclive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from onclive.com Daily Mail and Mail on Sunday newspapers.
The Japanese Ministry of Health, Labour and Welfare has approved zolbetuximab for CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer.
Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb.