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Revlimid for Multiple Myeloma - Details

Project Number pCODR 10029
Brand Name Revlimid
Generic Name Lenalidomide
Strength 5mg, 10mg, 15mg and 25mg capsules
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request For the maintenance treatment of newly diagnosed multiple myeloma in patients after 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 April 5, 2013
Submission Deemed Complete April 19, 2013
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 19, 2013
Check-point meeting August 6, 2013
pERC Meeting September 19, 2013
Initial Recommendation Issued October 3, 2013
Feedback Deadline ‡ October 18, 2013
Final Recommendation Issued October 22, 2013
Notification to Implement Issued November 6, 2013

‡ 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.