European Commission Grants Approval of OGSIVEO® (Nirogacestat) for the Treatment of Adults with ...

European Commission Grants Approval of OGSIVEO® (nirogacestat) for the Treatment of Adults with ...

STAMFORD, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted marketing authorization for OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for…

Nirogacestat Receives European Approval for Treatment of Desmoid Tumors

The EC decision is based on phase 3 DeFi trial results, in which nirogacestat met the primary end point of PFS in patients with progressing desmoid tumors.

Ogsiveo approved in EU for treatment of desmoid tumors

Merck’s therapy becomes first authorised option for aggressive soft tissue tumours

First-Ever Treatment for Desmoid Tumors: SpringWorks' OGSIVEO Shows 71% Disease Control in EU Approval

OGSIVEO demonstrates 71% reduction in disease progression risk and 41% response rate in Phase 3 trial. First approved therapy for 1,300-2,300 annual EU desmoid tumor patients.