Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration has granted approval for VYLOY (zolbetuximab-clzb) to be used with a regimen of fluoropyrimidine- and platinum-based chemotherapy. This combination is approved for the initial treatment of adults suffering from locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, specifically in cases where tumors test positive for claudin (CLDN) 18.2, as determined by an FDA-approved diagnostic test.
Remarkably, VYLOY stands as the first CLDN18.2-targeted therapy to receive approval in the U.S. for adults with advanced stages of gastric and GEJ cancer exhibiting CLDN18.2 positivity.
Astellas has partnered with Roche to develop an immunohistochemistry (IHC) companion diagnostic (CDx) test designed to pinpoint patients who might benefit from VYLOY therapy.
In related news, Roche revealed that its VENTANA CLDN18 (43-14A) RxDx Assay is the inaugural FDA-approved IHC companion diagnostic test for identifying CLDN18 protein expression in gastric or GEJ adenocarcinoma tumors. This offers a pathway for patients to receive treatment with Astellas' targeted therapy, VYLOY (zolbetuximab).
