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| Project Number | pCODR 10204 |
|---|---|
| Brand Name | Blincyto |
| Generic Name | Blinatumomab |
| Strength | 38.5 mcg |
| Tumour Type | Leukemia |
| Indication | Minimal Residual Disease (MRD)-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (BCP ALL) |
| Funding Request | Patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1% |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | December 19, 2019 |
| Manufacturer | Amgen Canada Inc |
| Sponsor | Amgen Canada Inc |
| Submission Date | January 20, 2020 |
| Submission Deemed Complete | February 3, 2020 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | February 3, 2020 |
| Check-point meeting | April 9, 2020 |
| pERC Meeting (target date) | August 20, 2020 |
| 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.