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

The US FDA has rejected Astellas Pharma’s application for the first drug approval for gastrointestinal cancer treatment, zolbetuximab, due to “unresolved deficiencies” in its manufacturing process. Despite the setback, Astellas confirmed that there had been no concerns raised over the safety or efficacy of the drug. Zolbetuximab is aimed at patients with HER2-negative, locally advanced or metastatic gastrointestinal adenocarcinoma, which currently lacks sufficient treatment options. Astellas acquired the drug as part of its 2016 purchase of Ganymede Pharmaceuticals.

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