Core Insights - The European Commission has granted marketing authorization for OGSIVEO (nirogacestat), making it the first and only approved therapy in the EU for treating desmoid tumors [1][2][3] Company Overview - SpringWorks Therapeutics, a healthcare company of Merck KGaA, is focused on developing treatments for rare tumors and has successfully launched OGSIVEO as a systemic therapy for desmoid tumors in both the U.S. and Europe [1][3][15] - The company aims to improve patient outcomes and quality of life for those affected by rare tumors, highlighting its commitment to the rare tumor patient community [3][15] Industry Context - Desmoid tumors are rare, locally aggressive tumors with an annual diagnosis rate of approximately 1,300 to 2,300 cases in the EU, causing significant pain and functional limitations for patients [2][7] - The approval of OGSIVEO is seen as a significant advancement in the management of desmoid tumors, which previously had no approved treatments in Europe [2][3] Clinical Trial Insights - The approval of OGSIVEO is based on the Phase 3 DeFi trial, which demonstrated a 71% reduction in the risk of disease progression compared to placebo, with a confirmed objective response rate of 41% [3][5][6] - The trial included 142 adult patients and met its primary endpoint of improving progression-free survival [3][5] Treatment Efficacy - OGSIVEO has shown significant improvements in patient-reported outcomes, including pain reduction and overall health-related quality of life [3][4][6] - The therapy is positioned as a first-line intervention for desmoid tumors, shifting the treatment paradigm away from surgical options [2][8]