Manufacturing issues trigger FDA rejection of Astellas’s gastric cancer antibody

09 Jan 2024
firstwordpharma.com
Phase 3Priority ReviewClinical ResultADCASCO
After stellar data secured FDA priority review of Astellas’s experimental gastric cancer treatment this past summer, the drugmaker is now scrambling to address third-party manufacturing deficiencies that led the agency to issue a complete response letter (CRL) ahead of the scheduled January 12 PDUFA date.
Astellas disclosed the rejection on Monday, which did not cite any issues with the efficacy or safety data of zolbetuximab, a CLDN18.2-targeted monoclonal antibody. The company said it’s working closely with the FDA and its manufacturer to “establish a timeline to quickly resolve the agency’s feedback.”
The FDA was evaluating a marketing application for zolbetuximab as first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2-positive.
The application was based on the Phase III GLOW and SPOTLIGHT studies, which found that in the specific gastric cancer patient population, zolbetuximab reduced the risk of progression or death by 31.3% and 24.9%, respectively, versus placebo.
Prior to Monday’s CRL, the programme was on track to become the first approved cancer therapy targeting CLDN18.2 – an area attracting significant investment. According to a FirstWord poll conducted in June, the majority of participating oncologists expect zolbetuximab to quickly become a new standard of care among the HER2-negative, CLDN18.2-positive gastric cancerCLDN18.2-positive gastric cancer patient population. For more, see KOL Views Q&A: Leading oncologist excited to get to work learning how to use zolbetuximab in gastric cancer.
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