| Project Number | pCODR 10190 |
|---|---|
| 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 | Under Review |
| 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 |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | August 23, 2019 |
| Check-point meeting | October 29, 2019 |
| pERC Meeting | January 16, 2020 |
| Initial Recommendation Issued (target date) | January 30, 2020 |
| Feedback Deadline (target date) ‡ | February 13, 2020 |
| 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.