A Multicenter Phase 3 Randomized, Open-label Study Of Bosutinib Versus Imatinib In Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Trial Profile

A Multicenter Phase 3 Randomized, Open-label Study Of Bosutinib Versus Imatinib In Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 May 2018

At a glance

  • Drugs Bosutinib (Primary) ; Imatinib
  • Indications Chronic myeloid leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms BFORE
  • Sponsors Avillion; Pfizer
  • Most Recent Events

    • 16 May 2018 According to the Pfizer media release, long term efficacy and safety results from this trial will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2018.
    • 23 Feb 2018 The European CHMP of the EMA has granted a positive opinion recommending marketing authorization of BOSULIF (bosutinib) for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), in the European Union. The MAA for BOSULIF was based on data this trial.
    • 19 Dec 2017 Results published in an Avillion Media Release.
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