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Blincyto for Philadelphia Chromosome positive B-cell precursor Acute Lymphoblastic Leukemia – Details

Project Number pCODR 10146
Brand Name Blincyto
Generic Name Blinatumomab
Strength 38.5 mcg
Tumour Type Leukemia
Indication Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL)
Funding Request Adult patients (i.e., >= 18 years) with Ph+ BCP-ALL, who have relapsed after or are refractory to at least one second-generation or later TKI, or are intolerant to second-generation or later TKIs and intolerant or refractory to imatinib
Review Status Under Review
Pre Noc Submission No
NOC Date March 5, 2018
Manufacturer Amgen Canada Inc.
Submitter Amgen Canada Inc.
Submission Date August 31, 2018
Submission Deemed Complete September 17, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ September 17, 2018
Check-point meeting October 24, 2018
pERC Meeting (target date) January 17, 2019
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.