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Fedratinib (Inrebic) for Myelofibrosis - Details

Project Number pCODR 10205
Brand Name Inrebic
Generic Name Fedratinib
Strength 100 mg
Tumour Type Other
Indication Myelofibrosis
Funding Request For the treatment of splenomegaly and/or disease-related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.
Review Status Pending
Pre Noc Submission No
NOC Date July 27, 2020
Manufacturer Celgene Inc.
Sponsor Celgene Inc.
Submission Date (Target Date) November 5, 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) ‡ November 19, 2020
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.