Vyloy® (zolbetuximab-clzb) – New orphan drug approval
October 18, 2024 - Astellas announced the FDA approval of 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.
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