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A pivotal trial to investigate the efficacy and safety of ERY-ASP in adults with newly diagnosed acute lymphoblastic leukaemia

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Trial Profile

A pivotal trial to investigate the efficacy and safety of ERY-ASP in adults with newly diagnosed acute lymphoblastic leukaemia

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2018

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At a glance

  • Drugs ERY-ASP (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors ERYtech Pharma

Most Recent Events

  • 24 Jun 2018 According to a ERYtech Pharma media release, the company has ceased the development of Eryaspase in Acute Lymphoblastic Leukemia (ALL)including the withdrawal of its European MAA, based on recent feedback from the regulatory agencies in Europe and the United States, which states that, the company would require an additional investment in order to seek regulatory approval of eryaspase for the treatment of ALL.
  • 24 Jun 2018 Status changed from planning to withdrawn prior to enrolment, according to a ERYtech Pharma media release.
  • 11 Sep 2017 According to an ERYtech Pharma media release, the company expects the potential launch of this trial over next twelve months.

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