VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S.
for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO , Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc.
(TSE: 4503, President and CEO: Naoki Okamura , "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOYTM (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.
2 positive as determined by an FDA-approved test. 1 VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.
S. In the SPOTLIGHT and GLOW clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive.
2,3 CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, as determined by the VENTANA ® CLDN18 (43-14A) RxDx Assay from Roche. 2,3 Astellas collaborated with Roche on the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who may be eligible for VYLOY.
4 Moitreyee Chatterjee-Kishore , Ph.D., M.
B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas "The approval of VYLOY as the .
