Glasdegib (Daurismo) for acute myeloid leukemia- Details

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Generic Name:
Glasdegib
Project Status:
Complete
Therapeutic Area:
Acute Myeloid Leukemia (AML)
Manufacturer:
Pfizer Canada ULC
Brand Name:
Daurismo
Project Line:
Reimbursement Review
Project Number:
PC0207-000
NOC Status at Filing:
Post NOC
Strength:
25 mg and 100 mg
Tumour Type:
Leukemia
Indications:
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.
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:
Do not reimburse
pERC Meeting:
Final Recommendation 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.