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| 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. |
| Sponsor | 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.
