Naxitamab

Drug Profile

Naxitamab

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: 10 Jul 2017

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

Most Recent Events

  • 06 Dec 2017 Y-mAbs Therapeutics plans a phase III trial for Neuroblastoma (Combination therapy, Second-line therapy, In children, adolescents, adults) in USA, Denmark and United Kingdom (IV,infusion) (NCT03363373)
  • 10 Jul 2017 hu3F8 receives rare paediatric disease status for Neuroblastoma in USA
  • 12 Jun 2017 Memorial Sloan Kettering Cancer Center and Y-Mabs initiates enrolment in a phase I/II trial for Neuroblastoma (Combination therapy) in USA (NCT03189706)
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