Astellas is working closely with the FDA and the third-party manufacturer to address the flagged deficiencies. Credits: JHVEPhoto/Shutterstock.com

The US Food and Drug Administration (FDA) has rejected the Biologics License Application (BLA) of Astellas Pharma’s zolbetuximab for gastric cancer on grounds of third-party manufacturing concerns.

In a 8 January press release, Astellas announced that the FDA’s complete response letter (CRL) stated that the agency flagged “unresolved deficiencies” during an inspection of a third-party manufacturing facility for the drug. Aside from manufacturing problems, the FDA has not specified any concerns pertaining to the clinical safety or efficacy of the treatment and has not requested additional clinical data. The FDA issued the CRL on 4 January, only days before the drug’s Prescription Drug User Fee Act (PDUFA) action date of 12 January.

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As per the company’s senior vice president and head of immune-oncology development Moitreyee Chatterjee-Kishore, Astellas is confident that zolbetuximab’s clinical profile can fill a “significant therapeutic gap” and is working with the FDA and the manufacturer to swiftly resolve the agency’s concerns.

In July 2023, the FDA granted zolbetuximab FDA priority review. The drug’s BLA was supported by positive data from the Phase III SPOTLIGHT (NCT03504397) study which evaluated a zolbetuximab/mFOLFOX6 combination treatment and the Phase III GLOW (NCT03653507) study which assessed zolbetuximab plus a chemotherapy regimen of capecitabine and oxaliplatin (CAPOX).

In addition to FDA, regulatory agencies in China and Japan are also actively reviewing the treatment. In August 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a BLA for zolbetuximab and in June 2023, Astellas submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour, and Welfare (MHLW).

Zolbetuximab, a first-in-class chimeric IgG1 monoclonal antibody designed to bind to Claudin (CLDN) 18.2 and induce cancer cell death, is intended for use as a first-line therapy for locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with CLDN 18.2 positive tumours.

GlobalData forecasts that zolbetuximab will bring in $756m by 2029.

GlobalData is the parent company of Pharmaceutical Technology.