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Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide. ....
The FDA has issued a complete response letter regarding the biologics license application seeking the approval of zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive ....
The FDA has granted a priority review to the biologics license application seeking the approval of zolbetuximab for the first-line treatment of patients with unresectable, locally advanced or metastatic, HER2-negative, gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive. ....
Kevin M. Waters, MD, PhD, discusses key findings from a study that reinforced the rationale for Claudin18.2 testing, the prevalence of this protein in gastric cancers, and how this potential therapeutic target represents the evolving role of pathology in cancer diagnosis and care. ....