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: 16 Oct 2017

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

    • 29 Aug 2017 According to a Pfizer media release, supplemental NDA for bosutinib to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia, has been accepted and granted priority review by the US FDA, The EMA validated for review a Type II Variation application for use of BOSULIF in the same patient population. The submissions were based on results from the this trial. The PDUFA date for decision by the US FDA is in December 2017.
    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association
    • 06 Jun 2017 Initial results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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