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: 06 Apr 2018

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At a glance

  • Originator Memorial Sloan-Kettering Cancer Center
  • Developer Memorial Sloan-Kettering Cancer Center; Y-mAbs Therapeutics
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action 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

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

Most Recent Events

  • 26 Feb 2018 Phase-III clinical trials in Neuroblastoma (Combination therapy, In adolescents, In adults, In children, In infants, In the elderly) in Spain, Denmark (IV) (EudraCT2017-001829-40)
  • 01 Jan 2018 Phase-III clinical trials in Neuroblastoma (Combination therapy, Second-line therapy or greater, In children, In adolescents, In adults, In infants) in USA (IV) (NCT03363373)
  • 06 Dec 2017 Y-mAbs Therapeutics plans a phase III trial for Neuroblastoma (Combination therapy, Second-line therapy, In children, adolescents, adults, In infants) in USA, Denmark and United Kingdom (IV,infusion) (NCT03363373)
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