By Jasmine Li
Astellas Pharma's drug Vyloy was approved for treatment of advanced gastric and gastroesophageal junction cancer by the Food and Drug Administration.
The pharmaceutical company said Friday the FDA approved the drug for use in combination with fluoropyrimidine-and-platinum-containing chemotherapy. Vyloy is intended for the first-line treatment of patients whose tumors are claudin $(CLDN.UK)$ 18.2 positive, Astellas said.
The approval was based on results from Phase 3 clinical trials, and makes Vyloy the first and only CLDN18.2-targeted therapy approved in the U.S., the company said.
An FDA-approved test developed by Roche Holdings is used to identify patients who may be eligible for Vyloy, Astellas said. Vyloy was also approved in Japan, the U.K., the E.U. and South Korea this year.
Write to Jasmine Li at jasmine.li@wsj.com
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October 18, 2024 15:29 ET (19:29 GMT)
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