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Blincyto for MRD-positive B-cell precursor ALL

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 Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Amgen Canada Inc.
Submitter 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 (target date) 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.