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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: 16 Dec 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

    • 16 Dec 2020 Results published in the Y-mAbs Therapeutics media release.
    • 25 Nov 2020 According to a Y-mAbs Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved DANYELZA (naxitamab-gqgk) 40mg/10ml for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
    • 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.
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