SpringWorks Therapeutics announced on June 20, 2025, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion. This opinion recommends the approval of nirogacestat as monotherapy for adults with progressing desmoid tumors who require systemic treatment.
The European Commission (EC) is expected to make a final decision regarding the approval in the third quarter of 2025. If approved, nirogacestat would be the first and only therapy with marketing authorization in the EU for the treatment of desmoid tumors.
The CHMP opinion was based on results from the Phase 3 DeFi trial, which demonstrated a 71% lower risk of disease progression compared to placebo (HR 0.29; p < 0.001). This positive recommendation is a significant step towards expanding OGSIVEO's availability beyond the U.S. market and addressing an unmet medical need in Europe.
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