SpringWorks Therapeutics' Ogsiveo Receives European Commission Approval for Desmoid Tumor Treatment

Approval Announcement: Merck announced that the European Commission has granted marketing authorization for Ogsiveo (nirogacestat) as a treatment for adults with progressing desmoid tumors requiring systemic therapy.

Significance of Ogsiveo: Ogsiveo is the first and only approved therapy in the EU for desmoid tumors, which are rare and challenging to manage due to their invasive nature and high recurrence rates.

Clinical Trial Results: The approval is based on the Phase 3 DeFi trial, which showed that Ogsiveo significantly improved progression-free survival compared to placebo, reducing the risk of disease progression by 71%.

Impact on Patients: Desmoid tumors can cause severe symptoms such as pain and loss of mobility, and the introduction of Ogsiveo offers hope for better management and quality of life for affected individuals.