The FDA has approved zolbetuximab for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma that is claudin 18.2 positive. This monoclonal antibody targets claudin 18.2 and triggers immune responses that kill cancer cells. Approval was delayed due to manufacturing plant issues but has since been resolved. Zolbetuximab is the first claudin 18.2 targeting agent approved in the US and has also been approved in Japan, Europe, and the UK. Clinical trials showed significant improvement in overall and progression-free survival when zolbetuximab was added to chemotherapy. The recommended dosage is 800 mg/m2 intravenously for the first dose and subsequent doses given every 3 weeks.
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FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer
