Blincyto for MRD-positive B-cell precursor ALL

Details

Generic Name:

Blinatumomab

Project Status:

Withdrawn

Manufacturer:

Amgen Canada Inc.

Brand Name:

Blincyto

Project Line:

Reimbursement Review

Project Number:

PC0143-000

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Withdrawn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:

June 29, 2018

Submission Deemed Complete:

July 9, 2018

Prioritization Requested:

Not Requested

Stakeholder Input Deadline ‡:

July 16, 2018

Check-point meeting:

August 29, 2018

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.

Last Updated : October 16, 2018