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| 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.
