European Commission Grants Approval for Merck KGaA's OGSIVEO as First-Ever Treatment for Desmoid Tumors in the EU

Reuters
2025.08.18 13:05
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Merck KGaA has received approval from the European Commission for OGSIVEO® (nirogacestat), the first treatment for desmoid tumors in the EU. This oral gamma secretase inhibitor is approved as a monotherapy for adults with progressing desmoid tumors needing systemic treatment. The approval follows positive results from the Phase 3 DeFi trial, showing improved progression-free survival and response rates. The authorization was granted to SpringWorks Therapeutics Inc., highlighting their dedication to rare tumor patients.