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A Phase II Preventative Trial of DFMO (Eflornithine HCl) as a Single Agent in Patients With High Risk Neuroblastoma in Remission

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Trial Profile

A Phase II Preventative Trial of DFMO (Eflornithine HCl) as a Single Agent in Patients With High Risk Neuroblastoma in Remission

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Apr 2025

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At a glance

  • Drugs Eflornithine (Primary)
  • Indications Neuroblastoma
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 17 Apr 2025 According to a Norgine media release, company announced that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy.
  • 07 Jan 2025 According to a Norgine media release, company announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB).
  • 15 Apr 2024 According to a Norgine media release, on 13 Dec 2023, the US Food and Drug Administration (FDA) approved eflornithine as the first oral maintenance therapy for high-risk neuroblastoma. The approval decision was based on findings from a trial comparing outcomes from Study 3b (NCT02395666; investigational arm) and Study ANBL0032 (NCT00026312; clinical-trial-derived external control arm).

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