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SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

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  • The EC has approved Ogsiveo as a monotx. for adults with progressing desmoid tumors needing systemic treatment
  • Approval was based on global P-III (DeFi) trial (N=142) assessing Ogsiveo (150mg, BID, n=70) vs PBO (n=72) in adults with progressing desmoid tumors
  • Trial met its 1EP with 71% reduction in risk of disease progression & showed improved ORR (41% vs 8%), CR (7% vs 0%), median time to first response (5.6 vs 11.1mos.) & PROs, incl. pain, desmoid tumor-specific symptoms, physical/role functioning, & overall health-related QoL; published in the NEJM

Ref: Springworks | Image: Springworks| Press Release

Related News:- The EC Grants Conditional Approval to SpringWorks Therapeutics’ Ezmekly for NF1-PN

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