At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for certain gastric cancers.
The EU has followed Japan and GB in approving Astellas' first-to-market claudin 18.2-targeted therapy Vyloy, clearing it for gastric and gastroesophageal junction (GEJ) cancer.
Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment