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Dinutuximab - National Cancer Institute/United Therapeutics Corporation

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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; OP 08; Unituxin

Latest Information Update: 02 Nov 2023

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At a glance

  • Originator National Cancer Institute (USA)
  • Developer National Cancer Institute (USA); New Approaches to Neuroblastoma Therapy Consortium; Ohara Pharmaceutical; St. John of God Foundation; United Therapeutics Corporation
  • 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 - Neuroblastoma
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 30 Sep 2023 National Cancer Institute (NCI) completes phase-II clinical trials in Osteosarcoma (Recurrent, Metastatic disease, Second-line therapy or greater) in Puerto Rico, New Zealand, Canada, Australia, USA (IV) (NCT02484443)
  • 13 Mar 2023 Launched for Neuroblastoma in Japan (IV) prior to March 2023
  • 03 Jun 2022 Initial efficacy and adverse events data from a phase II trial in Neuroblastoma presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022)
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