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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FDA Rejects GI Cancer Drug Over Manufacturing Issues
