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A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Trial Profile

A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Nov 2019

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At a glance

  • Drugs Naxitamab (Primary) ; Sargramostim
  • Indications Neuroblastoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Y-mAbs Therapeutics
  • Most Recent Events

    • 29 Nov 2019 According to an Y-mAbs Therapeutics media release, the company announced that it has submitted to the U.S. Food and Drug Administration (FDA) the first portions of its Biologics License Application (BLA) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA's Rolling Review process.
    • 13 Nov 2019 According to a Y-mAbs Therapeutics media release, the company expects to submit the first portion of the rolling BLA for naxitamab within the next few weeks.
    • 08 Jul 2019 According to a Y-mAbs Therapeutics media release, The Company expects to submit the Clinical/Safety portion and the non-Clinical portion of the BLA in November 2019. For the CMC portion, the Company believes it will have sufficient data from the process performance qualification ("PPQ") batches to complete the CMC portion in early 2020.
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