Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma, potentially making them eligible for Astellas’ Vyloy (zolbetuximab), a targeted therapy.
The approval of the VENTANA CLDN18 (43-14A) RxDx Assay is a clinical milestone, as it provides a definitive method to identify patients who could benefit from zolbetuximab. This qualitative assay assesses Claudin 18 (CLDN18) protein in gastric adenocarcinoma, including those at the gastroesophageal junction. The assay’s approval follows the successful SPOTLIGHT and GLOW clinical studies, which utilized the test to enroll patients with CLDN18.2 positive tumors. In these studies, the combination of zolbetuximab and chemotherapy demonstrated a significant 25-31% reduction in disease progression or death, offering a new hope for patients with limited treatment options.- Flcube.com
