SpringWorks Therapeutics, now a healthcare company of Merck, announced on August 18, 2025, that the European Commission (EC) granted marketing authorization for OGSIVEO (nirogacestat). This approval is for monotherapy treatment of adults with progressing desmoid tumors who require systemic treatment.
OGSIVEO is the first and only therapy approved in the European Union (EU) to treat desmoid tumors, addressing a significant unmet medical need for approximately 1,300 to 2,300 new cases diagnosed annually in the EU. This approval establishes OGSIVEO as the standard of care in Europe, mirroring its status in the U.S.
The EC approval was based on results from the Phase 3 DeFi trial, which showed a 71% reduction in the risk of disease progression compared to placebo (HR 0.29; p<0.001) and a confirmed objective response rate of 41% with OGSIVEO versus 8% with placebo (p<0.001). This milestone significantly expands OGSIVEO's global market reach and reinforces its therapeutic value.
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