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Naxitamab - Y-mAbs therapeutics

Drug Profile

Naxitamab - Y-mAbs therapeutics

Alternative Names: Hu3F8 (GD2); Hu3F8 - Y-mAbs Therapeutics; Hu3F8-Fce; Humanised 3F8 - Y-mAbs Therapeutics; Humanised anti-GD2 3F8 monoclonal antibody - Y-mAbs Therapeutics; Humanised IgG1 monoclonal GD2 antibody - Y-mAbs Therapeutics

Latest Information Update: 03 Dec 2019

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At a glance

  • Originator Memorial Sloan-Kettering Cancer Center
  • Developer Memorial Sloan-Kettering Cancer Center; Y-mAbs Therapeutics
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; GD2 ganglioside inhibitors
  • 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

  • Preregistration Neuroblastoma
  • Phase II Osteosarcoma
  • Discontinued Breast cancer; Sarcoma; Small cell lung cancer

Most Recent Events

  • 29 Nov 2019 Preregistration for Neuroblastoma (Combination therapy, In adolescents, In children, In infants, Second-line therapy or greater, In adults) in USA (IV)
  • 28 Oct 2019 No recent reports of development identified for phase-I development in Neuroblastoma(Monotherapy) in USA (IV, Infusion)
  • 25 Oct 2019 Efficacy data from a phase I/II trial in Neuroblastoma released by Y-mAbs Therapeutics
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