FDA approves Vyloy (zolbetuximab-clzb) for first-line treatment of advanced HER2-negative gastric cancer with CLDN18.2 positive tumors, with Roche'

The FDA has approved Vyloy (zolbetuximab-clzb) for treating adults with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors. This first-line therapy, used with chemotherapy, showed improved progression-free survival in clinical trials. Additionally, Roche’s VENTANA CLDN18 (43-14A) RxDx Assay was approved as a companion diagnostic to identify eligible patients, marking a significant step in targeted cancer treatment.

October 18, 2024
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