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Blinatumomab (Blincyto) for Acute Lymphoblastic Leukemia (pediatric) – Details

Project Number pCODR 10099
Brand Name Blincyto
Generic Name Blinatumomab
Strength 38.5mcg vial
Tumour Type Leukemia
Indication Pediatric Acute Lymphoblastic Leukemia (ALL)
Funding Request For the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)
Review Status Final Recommendation Posted
Pre Noc Submission Yes
NOC Date April 28, 2017
Manufacturer Amgen Canada Inc.
Submitter Amgen Canada Inc.
Submission Date February 24, 2017
Submission Deemed Complete March 3, 2017
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ March 10, 2017
Check-point meeting May 2, 2017
pERC Meeting July 20, 2017
Clarification The Manufacturer had initially advised that Category 2 submission requirements for a pre-NOC submission would not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements.
Initial Recommendation Issued August 3, 2017
Feedback Deadline ‡ August 18, 2017
Final Recommendation Issued August 23, 2017
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.