A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

Trial Profile

A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Moxetumomab pasudotox (Primary)
  • Indications Hairy cell leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors MedImmune
  • Most Recent Events

    • 03 Apr 2018 According to an AstraZeneca media release, results from this trial will be presented at a forthcoming medical meeting
    • 03 Apr 2018 Primary endpoint has been met. (Rate of CR in patients treated with study drug)
    • 03 Apr 2018 According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least two prior lines of therapy. The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act (PDUFA) date set for
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