FDA Rejects GI Cancer Drug Over Manufacturing Issues

The FDA has rejected approval of the cancer drug zolbetuximab due to manufacturing issues. The drug, developed by Astellas, was intended for treating a specific type of gastric cancer. The FDA’s decision was related to unresolved deficiencies in the manufacturing process at a third-party facility. The company is working to resolve the issues and clarified that the FDA did not request additional efficacy and safety data. If approved, pathologists will need to use a companion diagnostic test for claudin 18.2 before the drug can be used. The drug is also under review in Japan, Europe, and China.

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