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A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy

Trial Profile

A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2024

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At a glance

  • Drugs Momelotinib (Primary) ; Danazol
  • Indications Anaemia; Myelofibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms MOMENTUM
  • Sponsors Sierra Oncology

Most Recent Events

  • 12 Nov 2024 According to a GSK media release, Health Canada has approved Ojjaara (momelotinib) for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera MF or post essential thrombocythemia MF who have moderate to severe anemia.
  • 24 Jun 2024 According to a GSK Plc media release, based on data from phase 3 MOMENTUM trial (NCT04173494) and phase 3 SIMPLIFY-1 trial (NCT01969838) , Momelotinib has been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) in use for patients with myelofibrosis and anemia.
  • 04 Jun 2024 Results of exploratory analysis evaluating survival over the entire MOMENTUM trial period, presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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