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: 17 Apr 2024
Price :
$35
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At a glance
- Drugs Eflornithine (Primary)
- Indications Neuroblastoma
- Focus Registrational; Therapeutic Use
- 15 Apr 2024 According to a Norgine B.V. media release, company announced first marketing authorisation application submissions on 10 Apr 2024, seeking approval for eflornithine in high-risk neuroblastoma via Project Orbis in Australia, Switzerland and UK. 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).
- 14 Dec 2023 According to an US WorldMeds media release, based on results form this trial, the U.S. Food and Drug Administration (FDA) has approved IWILFIN (eflornithine) 192 mg tablets, a oral maintenance therapy for high-risk neuroblastoma.
- 05 Dec 2023 Status changed from active, no longer recruiting to completed.