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  • Will Astellas¡¯ gastric cancer drug Vyloy be approved in 2H?
  • by Eo, Yun-Ho | translator Kang, Shin-Kook | Aug 19, 2024 05:47am
Is under review by the MFDS
Showed improvement in overall survival in two Phase III trials
Zolbetuximab, a new targeted cancer therapy with a new mechanism of action for gastric cancer, may be commercialized in Korea in the second half of the year.

According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing Vyloy (zolbetuximab), a treatment for patients with CLDN18.2 positive, unresectable, advanced, or recurrent gastric cancer.

The drug was approved in Japan in March. Vyloy is an immunoglobulin (IgG)1 monoclonal antibody that targets Claudin 18.2, a cell surface protein expressed by gastric cancer cells. It binds to the claudin 18.2 protein expressed on the surface of cancer cells in gastric epithelial cells.

However, unfavorable conditions to its approval al
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