Dinutuximab beta

Drug Profile

Dinutuximab beta

Alternative Names: APN311; ch14.18/CHO; ISQETTE

Latest Information Update: 07 Oct 2016

Price : $50

At a glance

  • Originator Children's Cancer Research Institute
  • Developer Apeiron Biologics; Children's Cancer Research Institute; Nagoya University; SIOPEN
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action GD2 ganglioside inhibitors; Immunostimulants
  • Orphan Drug Status

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

    Yes - Neuroblastoma
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Neuroblastoma

Most Recent Events

  • 04 Oct 2016 Dinutuximab beta licensed to EUSA Pharma worldwide
  • 03 Oct 2016 University of Wisconsin plans a phase I trial for Neuroblastoma in USA, United Kingdom and Germany (NCT02914405)
  • 30 May 2015 Phase III development is ongoing in Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Israel, Italy, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom
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