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Dinutuximab - National Cancer Institute/United Therapeutics Corporation

Drug Profile

Dinutuximab - National Cancer Institute/United Therapeutics Corporation

Alternative Names: Anti-GD2 monoclonal antibody ch14.18; Ch14.18; ch14.18-UTC; Chimeric anti-GD2 monoclonal antibody; Unituxin

Latest Information Update: 07 Dec 2018

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At a glance

  • Originator National Cancer Institute (USA)
  • Developer National Cancer Institute (USA); New Approaches to Neuroblastoma Therapy Consortium; St. John of God Foundation; United Therapeutics Corporation
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cell death stimulants; GD2 ganglioside inhibitors; Immunomodulators
  • Orphan Drug Status

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

    Yes - Neuroblastoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuroblastoma
  • Phase II/III Small cell lung cancer
  • Discontinued Malignant melanoma

Most Recent Events

  • 25 Dec 2018 National Cancer Institute plans a phase II trial for Neuroblastoma (Newly Diagnosed, Combination therapy) in January 2019 (NCT03786783)
  • 29 Nov 2018 Registered for Neuroblastoma (Combination therapy, In adolescents, In children, In infants, Second-line therapy or greater) in Canada (IV)
  • 29 Nov 2018 United Therapeutics Corporation intends to launch dinutuximab, for the treatment of high-risk neuroblastoma in Canada, in first half of 2019
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