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| Project Number | pCODR 10143 |
|---|---|
| Brand Name | Blincyto |
| Generic Name | Blinatumomab |
| Tumour Type | Leukemia |
| Indication | Minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL) |
| Funding Request | For the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor ALL |
| Review Status | Withdrawn |
| Clarification | Amgen Canada Inc. has notified pCODR that the Category 2 submission requirements for the pre NOC submission of Blinatumomab (Blincyto) for MRD-positive B-cell precursor ALL 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 | Amgen Canada Inc. |
| Sponsor | Amgen Canada Inc. |
| Submission Date | June 29, 2018 |
| Submission Deemed Complete | July 9, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | July 16, 2018 |
| Check-point meeting | August 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.