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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 all adult patients with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL), including those who have had one prior line of therapy (i.e., adult patients who are refractory or patients who are in first or later relapse)
Review Status Under Review
Pre Noc Submission No
NOC Date December 22, 2015
Manufacturer Amgen Canada Inc.
Submitter Amgen Canada Inc.
Submission Date February 24, 2017
Submission Deemed Complete March 10, 2017
Submission Type Resubmission
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ March 10, 2017
Check-point meeting April 19, 2017
pERC Meeting June 15, 2017
Initial Recommendation Issued June 29, 2017
Feedback Deadline ‡ July 14, 2017
pERC Reconsideration Meeting August 18, 2017
Final Recommendation Issued (target date) August 31, 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.