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


( Last Updated : November 17, 2020)
Generic Name:
Blinatumomab
Project Status:
Complete
Therapeutic Area:
MRD+ ALL Resubmission
Manufacturer:
Amgen Canada Inc
Brand Name:
Blincyto
Project Line:
Reimbursement Review
Project Number:
PC0204-000
NOC Date:

Details


Strength:
38.5 mcg
Tumour Type:
Leukemia
Indications:
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:
Complete
Sponsor:
Amgen Canada Inc
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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%
pERC Meeting:
Final Recommendation Issued:

Files

‡ 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.