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| Project Number | pCODR 10139 |
|---|---|
| Brand Name | Beleodaq |
| Generic Name | Belinostat |
| Tumour Type | Lymphoma |
| Indication | Peripheral T-Cell Lymphoma (PTCL) |
| Funding Request | For the treatment of patients with relapsed or refractory PTCL |
| Review Status | Withdrawn |
| Clarification | Servier Canada Inc. has notified pCODR that the Category 2 submission requirements for the pre NOC submission of Belinostat (Beleodaq) for Peripheral T-Cell Lymphoma (PTCL) cannot be met at this time. As per pCODR Procedures C3.1.6, the pCODR program has stopped the review. |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Servier Canada Inc. |
| Sponsor | Servier Canada Inc. |
| Submission Date | June 29, 2018 |
| Submission Deemed Complete | July 9, 2018 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | July 16, 2018 |
| 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.