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Naxitamab - Y mAbs Therapeutics

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Drug Profile

Naxitamab - Y mAbs Therapeutics

Alternative Names: DANYELZA; Danyelza; Hu3F8; Hu3F8 (GD2); Hu3F8-Fce; Humanised 3F8; Humanised anti-GD2 3F8 monoclonal antibody - Memorial Sloan-Kettering Cancer Center/Y-mAbs Therapeutics; Humanised IgG1 monoclonal GD2 antibody - Memorial Sloan-Kettering Cancer Center/Y-mAbs Therapeutics; Naxitamab-gqgk

Latest Information Update: 18 Oct 2023

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At a glance

  • Originator Memorial Sloan-Kettering Cancer Center
  • Developer Memorial Sloan-Kettering Cancer Center; SciClone Pharmaceuticals; Takeda Israel; Wake Forest University Health Sciences; Y-mAbs Therapeutics
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Osteosarcoma; Neuroblastoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuroblastoma
  • Phase II Osteosarcoma
  • Discontinued Sarcoma; Small cell lung cancer; Triple negative breast cancer

Most Recent Events

  • 17 Oct 2023 Adverse events data from a phase II trial in Neuroblastoma released by Y mAbs Therapeutics
  • 28 Sep 2023 Registered for Neuroblastoma in Mexico (IV)
  • 02 Aug 2023 Memorial Sloan-Kettering Cancer Center and Y-mAbs Therapeutics completes a phase-I trial in Neuroblastoma (Monotherapy, In infants, In children, In adolescents, In adults, In the elderly) in USA (IV) (NCT01419834)
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