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

Project Number PC0146-000
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 Complete
Pre Noc Submission No
NOC Date March 5, 2018
Manufacturer Amgen Canada Inc.
Sponsor Amgen Canada Inc.
Submission Date August 31, 2018
Submission Deemed Complete September 17, 2018
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ September 17, 2018
Check-point meeting October 24, 2018
pERC Meeting January 17, 2019
Initial Recommendation Issued January 31, 2019
Feedback Deadline ‡ February 14, 2019
pERC Reconsideration Meeting March 21, 2019
Final Recommendation Issued April 4, 2019
Notification to Implement Issued April 22, 2019
Therapeutic Area Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.