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# FDA OKs Vyloy for Rare Gastric Cancer
- URL: https://www.fdaweb.com/fda-oks-vyloy-for-rare-gastric-cancer/
- Published: 2024-10-21T12:00:00.000Z
- Updated: 2026-09-14T14:44:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158025

FDA has approved an Astellas Pharma BLA for 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-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive as determined by an FDA-approved test.

The approval was based on data from the Phase 3 [SPOTLIGHT](https://www.astellas.com/en/system/files/news/2023-01/20230120%5Fen%5F1.pdf?utm%5Fsource=press%5Frelease&utm%5Fmedium=pr%20&utm%5Fcampaign=us%5Fvyloy%5Fapproval) and [GLOW](https://www.astellas.com/en/system/files/news/2023-03/20230322%5Fen%5F2.pdf?utm%5Fsource=press%5Frelease&utm%5Fmedium=pr%20&utm%5Fcampaign=us%5Fvyloy%5Fapproval) clinical trials. Both trials met their progression-free survival primary endpoint, as well as overall survival, which was a key secondary endpoint, according to the company. “Across the SPOTLIGHT and GLOW trials, the most common all-grade treatment-emergent adverse events reported in the Vyloy treatment arms were nausea, vomiting and decreased appetite,” it says.