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|Project Number||pCODR 10222|
|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.|
|Pre Noc Submission||No|
|Manufacturer||United Therapeutics Corp.|
|Sponsor||United Therapeutics Corp.|
|Submission Date (Target Date)||November 5, 2020|
|Submission Type||New Indication|
|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.