US FDA declines to approve Astellas' gastric cancer drug

Washington DC:

Japan's Astellas Pharma said on Monday the U.S. Food and Drug Administration (FDA) has declined to approve its experimental drug to treat a type of gastric cancer, citing issues related to a third-party manufacturer. The FDA has not raised any concerns related to the clinical data, and is not requesting additional clinical studies, Astellas said.

The company said it is working closely with the FDA and the third-party manufacturer to quickly resolve the regulator's feedback, adding that the decision does not affect any other Astellas product.

The antibody-based drug, zolbetuximab, is being developed to treat patients with a type of locally advanced unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma.