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Glasdegib (Daurismo) for acute myeloid leukemia- Details

Project Number pCODR 10207
Brand Name Daurismo
Generic Name Glasdegib
Tumour Type Leukemia
Indication Acute Myeloid Leukemia (AML)
Funding Request In combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients, who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Pfizer Canada ULC
Sponsor Pfizer Canada ULC
Submission Date May 6, 2020
Submission Deemed Complete June 18, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ May 21, 2020
Check-point meeting July 29, 2020
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.