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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2025

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At a glance

  • Drugs Nirogacestat (Primary)
  • Indications Fibroma
  • Focus Registrational; Therapeutic Use
  • Acronyms DeFi
  • Sponsors SpringWorks Therapeutics

Most Recent Events

  • 18 Aug 2025 According to a SpringWorks Therapeutics media release, Bernd Kasper, M.D., Ph.D., Professor, University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany, and principal investigator of this trial.
  • 18 Aug 2025 According to a SpringWorks Therapeutics media release, company announced today that the European Commission (EC) granted marketing authorization for OGSIVEO (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing desmoid tumors who require systemic treatment, approval is based on based on results from the Phase 3 DeFi trial
  • 20 Jun 2025 According to a SpringWorks Therapeutics media release, company that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of nirogacestat. The CHMP opinion was based on Phase 3 DeFi trial. The European Commission (EC) will review the CHMP opinion and is expected to make a final decision regarding the approval in the third quarter of 2025.

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