European Commission Approves OGSIVEO® (nirogacestat) for Treating Adults with Desmoid Tumors
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 18 2025
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Source: Newsfilter
Approval of OGSIVEO: The European Commission has granted marketing authorization for OGSIVEO (nirogacestat), the first approved treatment for adults with progressing desmoid tumors in the EU.
Impact on Patients: Desmoid tumors are rare and can severely affect quality of life; OGSIVEO has shown significant antitumor activity and improvement in symptoms, including pain reduction.
Clinical Trial Results: The approval is based on the Phase 3 DeFi trial, which demonstrated a 71% reduction in disease progression risk and a notable improvement in patient-reported outcomes.
Safety Profile: OGSIVEO has a manageable safety profile, with common side effects including diarrhea, rash, and ovarian toxicity, necessitating monitoring during treatment.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
