Astellas Pharma (TYO: 4503) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Claudin18.2 (CLDN18.2) targeting antibody Vyloy (zolbetuximab) in combination with a fluoropyrimidine- and platinum-based chemotherapy regimen for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are determined to be CLDN18.2 positive by an FDA-approved test. Notably, this approval came three weeks ahead of the original PDUFA date, November 9th. According to the press release, Vyloy is the first CLDN18.2 targeting therapy to be approved by the U.S. FDA.
In China, the marketing application for zolbetuximab (injectional zolbetuximab) was accepted by the National Medical Products Administration (NMPA) in August 2023 for the first-line treatment of CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients.
Claudin is an important protein in the tight junctions of normal tissues, with four transmembrane domains, and is involved in the regulation of paracellular permeability and transepithelial electrical conductance. CLDN18.2 is highly expressed in gastrointestinal cancers, including gastric cancer, making it an effective target for the treatment of gastric, pancreatic, and other solid tumors.
The FDA’s approval was primarily based on the positive results of the SPOTLIGHT and GLOW Phase 3 clinical trials. The SPOTLIGHT study evaluated the efficacy and safety of Vyloy combined with mFOLFOX6 (a chemotherapy regimen containing oxaliplatin, leucovorin, and fluorouracil) compared to placebo combined with mFOLFOX6. The GLOW study assessed the role of Vyloy combined with CAPOX (a chemotherapy regimen containing capecitabine and oxaliplatin) compared to placebo combined with CAPOX. Analysis showed that both studies met their primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS), with significant benefits observed for the Vyloy plus chemotherapy groups over the placebo plus chemotherapy groups.- Flcube.com
