European Commission Grants Approval for Merck KGaA's OGSIVEO as First-Ever Treatment for Desmoid Tumors in the EU
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.
Merck KGaA, a leading science and technology company based in Darmstadt, Germany, has announced that the European Commission (EC) has granted marketing authorization for OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor, as a monotherapy for adults with progressing desmoid tumors requiring systemic treatment. This marks the first and only therapy approved in the European Union for treating desmoid tumors. The approval is a significant advancement for desmoid tumor patients and is based on the successful results of the Phase 3 DeFi trial, which demonstrated a substantial improvement in progression-free survival and objective response rate. The approval was issued to SpringWorks Therapeutics Inc., a healthcare company affiliated with Merck KGaA, underscoring their commitment to the rare tumor patient community. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck KGaA published the original content used to generate this news brief on August 18, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
