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Unituxin for Neuroblastoma – Details

Project Number PC0154-000
Brand Name Unituxin
Generic Name Dinutuximab
Strength 3.5 mg / mL
Tumour Type Neurological
Indication Neuroblastoma
Funding Request To be used in combination with GM-CSF, IL-2 and Retinoic acid (RA) for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multi-agent, multimodal therapy
Review Status Complete
Pre Noc Submission Yes
NOC Date November 28, 2018
Manufacturer United Therapeutics Corp.
Sponsor United Therapeutics Corp.
Submission Date October 1, 2018
Submission Deemed Complete October 16, 2018
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ October 16, 2018
Check-point meeting November 29, 2018
pERC Meeting February 21, 2019
Initial Recommendation Issued March 7, 2019
Feedback Deadline ‡ March 21, 2019
Final Recommendation Issued March 26, 2019
Notification to Implement Issued April 10, 2019
Therapeutic Area Neuroblastoma
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.