FDA approves Vyloy (zolbetuximab-clzb) + chemotherapy to treat EGFR receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma
Astellas Pharma Inc. announced that the FDA has approved Vyloy (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
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.CLDN18.2 positivity is defined as greater than 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immuno-histochemical staining, as determined by the Ventana CLDN18 (43-14A) RxDx Assay from Roche. Astellas collaborated with Roche on the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who may be eligible for Vyloy.
Samuel J. Klempner, M.D., Associate Professor, Harvard Medical School, Medical Oncologist at Massachusetts General Hospital, Boston ; "While there have been advances in the first-line treatment of locally advanced unresectable and metastatic gastric and GEJ cancers in the last several years, there is still a tremendous unmet need among our patients. The approval of Vyloy based on the pivotal Phase III SPOTLIGHT and GLOW trials, brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those on the frontlines of treatment decision-making."
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