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Unituxin for Neuroblastoma – Details

Project Number pCODR 10154
Brand Name Unituxin
Generic Name Dinutuximab
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 Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer United Therapeutics Corp.
Submitter United Therapeutics Corp.
Submission Date October 1, 2018
Submission Deemed Complete October 16, 2018
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ October 16, 2018
Check-point meeting (target date) November 29, 2018
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.