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| Project Number | pCODR 10064 |
|---|---|
| Brand Name | Blincyto |
| Generic Name | Blinatumomab |
| Strength | 38.5 µg (mcg) vial |
| Tumour Type | Leukemia |
| Indication | Acute Lymphoblastic Leukemia |
| Funding Request | For the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL) |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | December 22, 2015 |
| Manufacturer | Amgen Canada Inc. |
| Sponsor | Amgen Canada Inc. |
| Submission Date | August 24, 2015 |
| Submission Deemed Complete | August 31, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | September 8, 2015 |
| Check-point meeting | October 19, 2015 |
| pERC Meeting | January 21, 2016 |
| Clarification | The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission were not available to complete the submission for a December pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met |
| Initial Recommendation Issued | February 4, 2016 |
| Feedback Deadline ‡ | February 19, 2016 |
| pERC Reconsideration Meeting | March 17, 2016 |
| Final Recommendation Issued | April 1, 2016 |
| Notification to Implement Issued | April 18, 2016 |
‡ 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.
