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Blincyto for Acute Lymphoblastic Leukemia (Resubmission) – Details

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 adult patients with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)
Review Status Pending
Pre Noc Submission No
NOC Date December 22, 2015
Manufacturer Amgen Canada Inc.
Submitter Amgen Canada Inc.
Submission Date (Target Date) February 24, 2017
Submission Type Resubmission
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ March 10, 2017
Clarification The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date has been provided by the submitter.  A confirmed stakeholder input deadline date will be provided when the submission is received by pCODR.
Check-point meeting (target date)
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.