Gemtuzumab Ozogamicin (Mylotarg) for Acute Myeloid Leukemia — Details


( Last Updated : April 20, 2020)
Generic Name:
Gemtuzumab Ozogamicin
Project Status:
Complete
Therapeutic Area:
Acute Myeloid Leukemia (AML)
Manufacturer:
Pfizer Canada ULC
Brand Name:
Mylotarg
Project Line:
Reimbursement Review
Project Number:
PC0190-000
NOC Status at Filing:
Pre NOC
NOC Date:

Details


Strength:
4.5 mg/vial
Tumour Type:
Leukemia
Indications:
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
Pre Noc Submission:
Yes
Sponsor:
Pfizer Canada ULC
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse
pERC Meeting:
Final Recommendation Issued:

Files

‡ 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.