Astellas Pharma made an announcement confirming that the U.S. Food and Drug Administration (FDA) has accepted the Biologics Licence Application (BLA) for zolbetuximab and granted it Priority Review status. Zolbetuximab is a first-in-class investigational monoclonal antibody that targets Claudin 18.2 (CLDN18.2) and is being developed for the 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. Zolbetuximab, if approved, will mark a significant milestone as the first targeted therapy in the United States specifically designed to target CLDN18.2-positive solid tumours. This approval bring new treatment options to patients, potentially offering improved outcomes and tailored therapeutic approaches. The acceptance of the Biologics Licence Application filing and the granting of Priority Review designation by the FDA highlight the urgent therapeutic need for this treatment option. The Biologics Licence Application (BLA) for zolbetuximab was submitted based on the results from the Phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab in combination with mFOLFOX6, which includes oxaliplatin, leucovorin, and fluorouracil.
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