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Revlimid (in combo) bortezomib + dexamethasone for newly diagnosed Multiple Myeloma – Details

Project Number pCODR 10141
Brand Name Revlimid
Generic Name Lenalidomide
Strength 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request The combination of lenalidomide, bortezomib, and low-dose dexamethasone, for the treatment of newly diagnosed multiple myeloma patients in whom stem cell transplantation is not intended
Review Status Under Review
Pre Noc Submission No
NOC Date N/A
Manufacturer Celgene Inc.
Submitter Celgene Inc.
Submission Date (Target Date) December 21, 2018
Submission Deemed Complete January 14, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ January 14, 2019
Check-point meeting March 5, 2019
pERC Meeting (target date) May 16, 2019
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.