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Phase I/II Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Trial Profile

Phase I/II Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Jun 2020

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At a glance

  • Drugs Naxitamab (Primary) ; Granulocyte macrophage colony stimulating factor
  • Indications Neuroblastoma
  • Focus Adverse reactions; Registrational
  • Most Recent Events

    • 02 Jun 2020 According to a Y-mAbs Therapeutics media release, the Agency also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.
    • 02 Jun 2020 According to a Y-mAbs Therapeutics media release, based on phase 2 studies 201 and 12-230, the Biologics License Application (BLA) for Danyelza (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration (FDA). The FDA set an action date of November 30, 2020, under the Prescription Drug User Fee Act (PDUFA).
    • 01 Apr 2020 According to a Y-mAbs Therapeutics media release, the Company has completed the submission of its Biologics License Application (BLA) under the FDA's Rolling Review process for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 201 and 12-230.
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