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A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor

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

Latest Information Update: 19 Jun 2025

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At a glance

  • Drugs Pimicotinib (Primary)
  • Indications Giant cell tumour of tendon sheath
  • Focus Registrational; Therapeutic Use
  • Acronyms MANEUVER
  • Sponsors Abbisko Therapeutics

Most Recent Events

  • 10 Jun 2025 According to Merck and Co media release, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company's application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The application is based on results from Part 1 of the global Phase 3 MANEUVER study.
  • 10 Jun 2025 According to Abbisko Therapeutics media release, based upon results from part 1 of this trial the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT).
  • 28 May 2025 According to Merck and Co media release, the results will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

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