Astellas (ALPMY.US) CLDN18.2 antibody approved for first-line treatment of advanced cancer
On October 20, Astellas (ALPMY.US) announced that the U.S. FDA has approved Vyloy (zolbetuximab), its anti-Claudin18.2 (CLDN18.2) antibody, in combination with a chemotherapy regimen containing fluoropyrimidine and platinum, for the first-line treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are positive for CLDN18.2 as determined by an FDA-approved test. Notably, this approval is three weeks ahead of the original PDUFA date of November 9. According to the press release, Vyloy is the first FDA-approved CLDN18.2-targeted therapy. Gastric cancer is one of the most common cancers worldwide and is also one of the leading causes of cancer deaths. Adenocarcinoma is the major histological subtype of gastric cancer, accounting for over 90% of reported cases worldwide. According to statistics, more than 70% of gastric cancer patients are diagnosed at an advanced stage, and they urgently need innovative therapies. Claudin is an important protein in the tight junction of normal tissues, with four transmembrane domains, which regulates the processes of cell paracellular permeability and conductivity. CLDN18.2 is highly expressed in digestive tract cancers, including gastric cancer. Therefore, CLDN18.2 is an effective target for the treatment of gastric cancer, pancreatic cancer, etc.