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|Project Number||pCODR 10190|
|Generic Name||Gemtuzumab Ozogamicin|
|Indication||Acute Myeloid Leukemia|
|Funding Request||In combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||November 28, 2019|
|Manufacturer||Pfizer Canada ULC|
|Sponsor||Pfizer Canada ULC|
|Submission Date||August 9, 2019|
|Submission Deemed Complete||August 23, 2019|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||August 23, 2019|
|Check-point meeting||October 29, 2019|
|pERC Meeting||January 16, 2020|
|Initial Recommendation Issued||January 30, 2020|
|Feedback Deadline ‡||February 13, 2020|
|pERC Reconsideration Meeting||March 19, 2020|
|Final Recommendation Issued||April 2, 2020|
|Notification to Implement Issued||April 20, 2020|
‡ 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.