EMA Validates Marketing Authorization Application for Varegacestat in Desmoid Tumors

The European Medicines Agency (EMA) has validated a marketing authorization application (MAA) for varegacestat, a new treatment for adult patients with desmoid tumors. This validation initiates the EMA's centralized review process. The application is supported by findings from the Phase 3 RINGSIDE trial, which demonstrated that varegacestat significantly improved progression-free survival and objective response rates compared to placebo.