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Glasdegib (Daurismo) for acute myeloid leukemia- Details

Project Number PC0207-000
Brand Name Daurismo
Generic Name Glasdegib
Strength 25 mg and 100 mg
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 Complete
Pre Noc Submission Yes
NOC Date April 28, 2020
Manufacturer Pfizer Canada ULC
Sponsor Pfizer Canada ULC
Submission Date May 6, 2020
Submission Deemed Complete June 18, 2020
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ May 21, 2020
Check-point meeting July 29, 2020
pERC Meeting October 15, 2020
Initial Recommendation Issued October 29, 2020
Feedback Deadline ‡ November 12, 2020
pERC Reconsideration Meeting December 17, 2020
Final Recommendation Issued January 8, 2021
Notification to Implement Issued January 25, 2021
Therapeutic Area Acute Myeloid Leukemia (AML)
Recommendation Type Do not 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.