| Project Number | pCODR 10154 |
|---|---|
| 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 | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | November 28, 2018 |
| 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 | November 29, 2018 |
| pERC Meeting (target date) | February 21, 2019 |
| 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.
