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Gemtuzumab Ozogamicin (Mylotarg) for Acute Myeloid Leukemia — Details

Project Number PC0190-000
Brand Name Mylotarg
Generic Name Gemtuzumab Ozogamicin
Strength 4.5 mg/vial
Tumour Type Leukemia
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 Complete
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 Initial
Prioritization Requested
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
Therapeutic Area Acute Myeloid Leukemia (AML)
Recommendation Type Reimburse

‡ 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.