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| Project Number | pCODR 10097 |
|---|---|
| Brand Name | Blincyto (Resubmission) |
| Generic Name | Blinatumomab |
| Strength | 38.5mcg vial |
| Tumour Type | Leukemia |
| Indication | Adult Acute Lymphoblastic Leukemia (ALL) |
| Funding Request | For the treatment of all adult patients with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL), including those who have had one prior line of therapy (i.e., adult patients who are refractory or patients who are in first or later relapse) |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | December 22, 2015 |
| Manufacturer | Amgen Canada Inc. |
| Sponsor | Amgen Canada Inc. |
| Submission Date | February 24, 2017 |
| Submission Deemed Complete | March 10, 2017 |
| Submission Type | Resubmission |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | March 10, 2017 |
| Check-point meeting | April 19, 2017 |
| pERC Meeting | June 15, 2017 |
| Initial Recommendation Issued | June 29, 2017 |
| Feedback Deadline ‡ | July 14, 2017 |
| pERC Reconsideration Meeting | August 18, 2017 |
| Final Recommendation Issued | August 31, 2017 |
| Notification to Implement Issued | September 18, 2017 |
‡ 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.
