Dinutuximab beta

Drug Profile

Dinutuximab beta

Alternative Names: APN 311; ch14.18/CHO; Dinutuximab beta Apeiron; ISQETTE

Latest Information Update: 30 Mar 2017

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
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Neuroblastoma

Most Recent Events

  • 23 Mar 2017 CHMP adopts positive opinion for dinutuximab beta for Neuroblastoma (In infants, In Children, In adolescents, In adults, Second-line therapy or greater, Relapsed, Refractory metastatic disease) in European Union
  • 04 Oct 2016 Apeiron Biologics announces intention to submit NDA to US FDA for Neuroblastoma in 2017
  • 04 Oct 2016 Dinutuximab beta licensed to EUSA Pharma worldwide
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