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Fedratinib (TBD) for Myelofibrosis - Details

Project Number pCODR 10205
Brand Name TBD
Generic Name Fedratinib
Tumour Type Other
Indication Myelofibrosis
Funding Request For patients with intermediate to high risk symptomatic myelofibrosis as assessed using the Dynamic International Prognostic Scoring System (DIPSS) Plus or patients with symptomatic splenomegaly. Patients should have a an ECOG performance status ≤2 and be either previously untreated or refractory to other treatment.
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Celgene Inc.
Sponsor Celgene Inc.
Submission Date (Target Date) April 30, 2020
Clarification The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date has been provided.
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡
Check-point meeting (target date)
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.