January 09, 2024
FDA raised concerns regarding manufacturing facility of Astellas' zolbetuximab but had no comments on efficacy and safety
Astellas Pharma has shared an update on the progress of the Biologics License Application (BLA) for zolbetuximab, an investigational treatment designed for patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma featuring claudin (CLDN) 18.2 positive tumors.
On January 4, 2024, the U.S. Food and Drug Administration (FDA) issued a complete response letter, noting unresolved issues identified during its pre-license inspection of a third-party manufacturing facility for zolbetuximab.
Crucially, the FDA did not express any concerns regarding the clinical data, encompassing efficacy and safety, of zolbetuximab. Additionally, there is no request for additional clinical studies.
Astellas is actively collaborating with both the FDA and the third-party manufacturer to swiftly address and resolve the identified issues. The company is diligently working to establish a timeline for resolution. It's important to clarify that this development does not impact any other products within the Astellas portfolio.
Zolbetuximab, characterized as an investigational, first-in-class chimeric IgG1 monoclonal antibody (mAb), specifically targets and binds to claudin 18.2 (CLDN18.2), a transmembrane protein.