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Blincyto for MRD-positive B-cell precursor ALL — Details

Project Number pCODR 10204
Brand Name Blincyto
Generic Name Blinatumomab
Strength 38.5 mcg
Tumour Type Leukemia
Indication Minimal Residual Disease (MRD)-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (BCP ALL)
Funding Request Patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
Review Status Under Review
Pre Noc Submission No
NOC Date December 19, 2019
Manufacturer Amgen Canada Inc
Sponsor Amgen Canada Inc
Submission Date January 20, 2020
Submission Deemed Complete February 3, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ February 3, 2020
Check-point meeting April 9, 2020
pERC Meeting (target date) August 20, 2020
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.