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Kyprolis (with lenalidomide) for Multiple Myeloma – Details

Project Number pCODR 10067
Brand Name Kyprolis (with lenalidomide)
Generic Name Carfilzomib (with lenalidomide)
Strength 60 mg vial
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma following one prior treatment failure
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date January 15, 2016
Manufacturer Amgen Canada Inc.
Submitter Amgen Canada Inc.
Submission Date December 11, 2015
Submission Deemed Complete January 13, 2016
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ January 4, 2016
Check-point meeting March 1, 2016
pERC Meeting May 19, 2016
Initial Recommendation Issued June 3, 2016
Feedback Deadline ‡ June 17, 2016
Final Recommendation Issued June 21, 2016
Notification to Implement Issued July 7, 2016
Clarification The pERC Final Recommendation posted on June 21, 2016 was revised on November 11, 2016 in order to align the patient population in the pERC Recommendation with the pivotal trial (ASPIRE). The pCODR Provincial Advisory Group has been notified of this revision.

‡ 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.