EO-3021 is designed for GC/GEJ patients whose tumours express Claudin 18.2 and have progressed following prior therapy. The FTD status aims to accelerate the development and review of
The treatment targets those with folate receptor alpha (FRα)-positive, platinum-resistant, and high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three treatment
This designation will offer potential benefits such as tax credits and fee waivers to facilitate the drug’s development. The ODD status is intended for potential treatments for diseases
This approval is based on results from a multicentre, randomised, double-blind, placebo-controlled Phase III trial. The study’s co-primary endpoints were achieving a minimum of a 75% improvement in
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