China’s National Medical Products Administration (NMPA) has indicated on its website that Japan-based Astellas Pharma Inc. (TYO: 4503) has received approval for its drug Vyloy (zolbetuximab-clzb). The drug is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic claudin (CLDN) 18.2 positive, human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Zolbetuximab-clzb: A Claudin 18.2-Directed Cytolytic Antibody
Zolbetuximab-clzb is a Claudin 18.2-directed cytolytic antibody with the ability to specifically bind to CLDN18.2, a protein overexpressed in certain gastric cancers. By binding to CLDN18.2, zolbetuximab-clzb induces antibody dependent cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), which are mechanisms that contribute to the destruction of cancer cells.
Implications for Gastric Cancer Treatment
The approval of Vyloy by the NMPA expands the treatment options for patients with CLDN18.2 positive gastric or gastroesophageal junction adenocarcinoma in China. This marks a significant advancement in the targeted treatment of gastric cancer, particularly for those who have not responded to standard chemotherapy or for whom surgery is not an option.-Fineline Info & Tech
