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Dinutuximab (Unituxin) for Neuroblastoma (pediatric)

Project Number pCODR 10222
Brand Name Unituxin
Generic Name Dinutuximab
Tumour Type Neurological
Indication Neuroblastoma (pediatric)
Funding Request To be used in combination with granulocyte macrophage colony-stimulating factor, irinotecan and temozolomide for the treatment of pediatric patients with high-risk neuroblastoma who have relapsed following consolidation treatment, or who did not achieve a durable remission following consolidation treatment.
Review Status Pending
Pre Noc Submission No
NOC Date
Manufacturer United Therapeutics Corp.
Sponsor United Therapeutics Corp.
Submission Date (Target Date) November 5, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ November 19, 2020
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.