Astellas Pharma Inc. announced the FDA issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.
The FDA stated that the agency cannot approve the BLA by the Prescription Drug User Fee Act (PDUFA) action date of January 12, 2024, due to unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab. The FDA has not raised any concerns related to the clinical data, including efficacy or safety, of zolbetuximab, and is not requesting additional clinical studies. Astellas is working closely with the FDA and the third-party manufacturer to establish a timeline to quickly resolve the agency's feedback. No other Astellas products are affected.
Regulatory applications for zolbetuximab are also under review in several other countries and regions, including Japan, Europe, and China.
The impact of this matter on Astellas' financial results in the fiscal year ending March 31, 2024, will be limited.
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