FDA Issues Complete Response Letter to Astellas for Zolbetuximab BLA for GEJ Adenocarcinoma

The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

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