Manufacturing Issues Block Astellas From a First-in-Class Cancer Drug Approval

Astellas Pharma’s drug approval for zolbetuximab, a promising treatment for gastrointestinal cancer, has been delayed by the FDA due to manufacturing issues at a third-party facility. The FDA did not raise concerns about the drug’s safety or efficacy but cited unresolved deficiencies during the pre-license inspection. Zolbetuximab targets a specific protein found in stomach cells, offering a potential treatment option for HER2-negative gastric or gastroesophageal junction adenocarcinoma. The drug is part of Astellas’s growth strategy, aiming to offset the revenue decline of its top-selling product. The company remains confident in zolbetuximab’s potential and is committed to working with the FDA to bring it to patients as soon as possible, while other companies are also developing drugs targeting the same protein.

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