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These highlights do not include all the information needed to use VYLOY safely and effectively. See full prescribing information for VYLOY. VYLOY® (zolbetuximab-clzb) for injection, for intravenous useInitial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-prescription
VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated 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 [see Dosage and Administration (2.1) and Clinical Studies (14)].
- generic_name
- zolbetuximab
- product_names
- ZOLBETUXIMAB
- ndc
- 0469-3425, 0469-3425-10, 0469-4425, 0469-4425-30
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en