MedPage Today October 18, 2024
— Zolbetuximab indicated alongside fluoropyrimidine- and platinum-containing chemotherapy
The FDA approved zolbetuximab (Vyloy), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, in combination with chemotherapy for the first-line treatment of adults with advanced HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, the agency announced Friday.
“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,” said Samuel J. Klempner, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, in a press release from Astellas.
“The approval of Vyloy … brings forward a novel biomarker and new therapy for patients whose tumors are CLDN18.2 positive, and for those...
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