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Pomalyst for Multiple Myeloma - Details

Project Number PC0036-000
Brand Name Pomalyst
Generic Name Pomalidomide
Strength 1, 2, 3, 4 mg capsules
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request In combination with low-dose dexamethasone for patients with multiple myeloma for whom both bortezomib and lenalidomide have failed and who have received at least two prior treatment regimens and have demonstrated disease progression on the last regimen
Review Status Complete
Pre Noc Submission Yes
NOC Date January 20, 2014
Manufacturer Celgene Inc.
Sponsor Celgene Inc.
Submission Date January 13, 2014
Submission Deemed Complete January 20, 2014
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ January 27, 2014
Check-point meeting March 18, 2014
pERC Meeting May 15, 2014
Initial Recommendation Issued May 30, 2014
Feedback Deadline ‡ June 13, 2014
pERC Reconsideration Meeting July 17, 2014
Final Recommendation Issued July 31, 2014
Notification to Implement Issued August 18, 2014
Therapeutic Area Multiple Myeloma
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.