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| Project Number | pCODR 10146 |
|---|---|
| Brand Name | Blincyto |
| Generic Name | Blinatumomab |
| Strength | 38.5 mcg |
| Tumour Type | Leukemia |
| Indication | Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) |
| Funding Request | Adult patients (i.e., >= 18 years) with Ph+ BCP-ALL, who have relapsed after or are refractory to at least one second-generation or later TKI, or are intolerant to second-generation or later TKIs and intolerant or refractory to imatinib |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | March 5, 2018 |
| Manufacturer | Amgen Canada Inc. |
| Sponsor | Amgen Canada Inc. |
| Submission Date | August 31, 2018 |
| Submission Deemed Complete | September 17, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | September 17, 2018 |
| Check-point meeting | October 24, 2018 |
| pERC Meeting | January 17, 2019 |
| Initial Recommendation Issued | January 31, 2019 |
| Feedback Deadline ‡ | February 14, 2019 |
| pERC Reconsideration Meeting | March 21, 2019 |
| Final Recommendation Issued | April 4, 2019 |
| Notification to Implement Issued | April 22, 2019 |
‡ 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.
