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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: 15 Nov 2024

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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

  • 04 Nov 2024 Y-mAbs and Nobelpharma enters into a License and Distribution Agreement for development and commercialization of Naxitamab in Japan
  • 09 Sep 2024 Updated efficacy data from a phase II trial in neuroblastoma released by Y-mAbs Therapeutics
  • 12 Aug 2024 Launched for Neuroblastoma (Second-line therapy or greater) in Brazil (IV)

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