Blincyto for MRD-positive B-cell precursor ALL


( Last Updated : October 16, 2018)
Generic Name:
Blinatumomab
Project Status:
Withdrawn
Manufacturer:
Amgen Canada Inc.
Brand Name:
Blincyto
Project Line:
Reimbursement Review
Project Number:
PC0143-000

Details

Tumour Type:
Leukemia
Indications:
Minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Funding Request:
For the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor ALL
Review Status:
Withdrawn
Pre Noc Submission:
Yes
Sponsor:
Amgen Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
Clarification:
Amgen Canada Inc. has notified pCODR that the Category 2 submission requirements for the pre NOC submission of Blinatumomab (Blincyto) for MRD-positive B-cell precursor ALL cannot be met at this time. As per pCODR Procedures C3.1.6, the pCODR program has stopped the review.

‡ 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.