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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: 26 Jun 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

  • 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.
  • 28 Apr 2025 According to a Merck KGaA media release, marketing authorization application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with a Committee for Medicinal Products for Human Use (CHMP) decision expected in Q2 2025.
  • 20 Feb 2025 According to a SpringWorks Therapeutics media release, company presented long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with progressing desmoid tumors at the 2024 Connective Tissue Oncology Society Annual Meeting.

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