Astellas Pharma has announced the withdrawal of its marketing authorization application to the European Medicines Agency (EMA) for zolbetuximab. The drug was intended for the treatment of patients with CLDN18.2-positive, HER2-negative locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. This decision follows a recommendation from the EMA's Committee for Medicinal Products for Human Use (CHMP).
The CHMP's recommendation was based on concerns regarding the robustness of the data submitted and its applicability to the European Union patient population. While specific details of the concerns were not disclosed in the announcement, the CHMP typically evaluates the efficacy, safety, and quality data of a drug, as well as its risk-benefit profile, before making a recommendation.
Gastric cancer is a significant global health concern, with a high mortality rate due to late diagnosis and limited treatment options, especially in advanced stages. The 5-year survival rate for metastatic gastric cancer remains poor, highlighting the urgent need for novel therapies. Zolbetuximab, a monoclonal antibody targeting CLDN18.2, had shown promise in clinical trials as a potential targeted therapy for a subset of gastric cancer patients whose tumors overexpress this protein.
Despite the withdrawal in the EU, Astellas stated its commitment to continue working with regulatory agencies in other regions where zolbetuximab is under review. The company believes that zolbetuximab could still offer a valuable treatment option for patients with CLDN18.2-positive gastric cancer worldwide. The ongoing reviews will likely involve further scrutiny of the clinical data, including subgroup analyses and biomarker validation, to ensure the drug's efficacy and safety in specific patient populations.
