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AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

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Trial Profile

AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

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

Latest Information Update: 19 Aug 2024

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At a glance

  • Drugs Axatilimab (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Acronyms AGAVE-201
  • Sponsors Syndax Pharmaceuticals

    • Most Recent Events

    • 14 Aug 2024 According to an Incyte Corporation Media Release, based on data from his trial the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), for the treatment of chronic graft-versus-host disease (GVHD).
    • 14 May 2024 According to Incyte media release, data from this trial will be presented at the European Hematology Association 2024
    • 27 Feb 2024 According to an Incyte Corporation Media Release, the FDA has accepted the Biologics License Application (BLA) filing for axatilimab, an anti-CSF-1R antibody, in patients with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. The application has been granted Priority Review and assigned a PDUFA action date of August 28, 2024.

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