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Revlimid for Newly Diagnosed MM – Details

Project Number pCODR 10061
Brand Name Revlimid
Generic Name Lenalidomide
Strength 5, 10, 15, 25 mg capsules
Tumour Type Myeloma
Indication Multiple Myeloma (newly diagnosed)
Funding Request In combination with low-dose dexamethasone, for treatment of newly diagnosed multiple myeloma patients who are not candidates for stem cell transplantation
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date N/A
Manufacturer Celgene Inc.
Submitter Celgene Inc.
Submission Date May 4, 2015
Submission Deemed Complete May 11, 2015
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 19, 2015
Check-point meeting July 7, 2015
pERC Meeting September 17, 2015
Initial Recommendation Issued October 1, 2015
Feedback Deadline ‡ October 16, 2015
pERC Reconsideration Meeting November 19, 2015
Final Recommendation Issued December 3, 2015
Notification to Implement Issued December 18, 2015

‡ 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.