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Gemtuzumab Ozogamicin (TBD) for Acute Myeloid Leukemia — Details

Project Number pCODR 10190
Brand Name TBD
Generic Name Gemtuzumab Ozogamicin
Tumour Type Leukemia
Indication Acute Myeloid Leukemia
Funding Request Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia.
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Pfizer Canada ULC
Sponsor Pfizer Canada ULC
Submission Date August 9, 2019
Submission Deemed Complete August 23, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ August 23, 2019
Check-point meeting (target date) October 29, 2019
pERC Meeting (target date)
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.