New Oral Therapy Approved in the European Union for Adults with Desmoid Tumors
In August 2025, the European Commission (EC) approved a new oral therapy for adults with progressing desmoid tumors, a rare and complex sarcoma subtype. Following approval by the U.S. Food and Drug Administration in late 2023, OGSIVEO® (nirogacestat), developed by SpringWorks Therapeutics, is now the first and only therapy authorized in the European Union (EU) to treat desmoid tumors. These tumors can cause severe pain, fatigue, and loss of mobility, and are challenging to manage due to their invasive nature and high recurrence rates.
Expanding Treatment Options
A clinical trial for OGSIVEO demonstrated slower tumor progression, meaningful tumor responses, and improvements in pain and quality of life, all while maintaining a manageable safety profile.
This therapy has already become a standard-of-care systemic treatment in the U.S. and now provides clinicians in the EU with a new, evidence-based option to help patients achieve better outcomes with fewer side effects. It also expands treatment choices beyond surgery and chemotherapy, offering hope for improved quality of life by slowing tumor progression and relieving debilitating symptoms, particularly in regions where options have been limited.
Advancing Research and Awareness
This approval highlights the need for continued research and international collaboration in rare sarcomas. It advances awareness of desmoid tumors, supports the development of new treatments, and brings the global community closer to a world free from sarcoma.
Read the full press release from SpringWorks Therapeutics.