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Besponsa for Acute Lymphoblastic Leukemia – Details

Project Number PC0121-000
Brand Name Besponsa
Generic Name Inotuzumab Ozogamicin
Strength 0.9 mg/vial
Tumour Type Leukemia
Indication Acute Lymphoblastic Leukemia (ALL)
Funding Request For the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Review Status Complete
Pre Noc Submission Yes
NOC Date March 15, 2018
Manufacturer Pfizer Canada Inc.
Sponsor Pfizer Canada Inc.
Submission Date November 13, 2017
Submission Deemed Complete November 20, 2017
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ November 27, 2017
Check-point meeting January 25, 2018
pERC Meeting April 19, 2018
Initial Recommendation Issued May 3, 2018
Feedback Deadline ‡ May 17, 2018
pERC Reconsideration Meeting June 21, 2018
Final Recommendation Issued July 6, 2018
Notification to Implement Issued July 23, 2018
Therapeutic Area 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.