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A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

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Trial Profile

A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2024

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At a glance

  • Drugs Vimseltinib (Primary)
  • Indications Giant cell tumour of tendon sheath
  • Focus Registrational; Therapeutic Use
  • Acronyms MOTION
  • Sponsors Deciphera Pharmaceuticals

    • Most Recent Events

    • 15 Aug 2024 According to an Ono Pharmaceutical media release, the U.S. Food and Drug Administration (FDA) accepted a priority review for the New Drug Application (NDA) on August 14 US time for vimseltinibfor the treatment of patients with tenosynovial giant cell tumor (TGCT), which is under development by Deciphera Pharmaceuticals, Inc..The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 17, 2025.
    • 15 Aug 2024 Results published in the Ono Pharmaceutical Media Release.
    • 17 Jul 2024 According to a Deciphera Pharmaceuticals media release, based upon data from this trial the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib for the treatment of patients with tenosynovial giant cell tumor (TGCT), The review of the MAA begins under the EMAs centralized review process for all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

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