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Blinatumomab (Blincyto) for Ph- ALL

Project Number PC0064-000
Brand Name Blincyto
Generic Name Blinatumomab
Strength 38.5 µg (mcg) vial
Tumour Type Leukemia
Indication Acute Lymphoblastic Leukemia
Funding Request For the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)
Review Status Complete
Pre Noc Submission Yes
NOC Date December 22, 2015
Manufacturer Amgen Canada Inc.
Sponsor Amgen Canada Inc.
Submission Date August 24, 2015
Submission Deemed Complete August 31, 2015
Submission Type Initial
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ September 8, 2015
Check-point meeting October 19, 2015
pERC Meeting January 21, 2016
Clarification The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission were not available to complete the submission for a December 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. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met
Initial Recommendation Issued February 4, 2016
Feedback Deadline ‡ February 19, 2016
pERC Reconsideration Meeting March 17, 2016
Final Recommendation Issued April 1, 2016
Notification to Implement Issued April 18, 2016
Therapeutic Area Acute Lymphoblastic Leukemia
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.