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Besponsa for Acute Lymphoblastic Leukemia – Details

Project Number pCODR 10121
Brand Name Besponsa
Generic Name Inotuzumab Ozogamicin
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 Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Pfizer Canada Inc.
Submitter Pfizer Canada Inc.
Submission Date November 13, 2017
Submission Deemed Complete November 20, 2017
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ November 27, 2017
Check-point meeting January 25, 2018
pERC Meeting (target date) April 19, 2018
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.