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| Project Number | pCODR 10079 |
|---|---|
| Brand Name | Darzalex |
| Generic Name | Daratumumab |
| Strength | 100mg/5mL and 400mg/20mL |
| Tumour Type | Myeloma |
| Indication | Multiple Myeloma |
| Funding Request | For the treatment of patients with multiple myeloma who 1) have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD); OR 2) have failed or are intolerant to a PI and who have failed or are intolerant to an IMiD |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | June 29, 2016 |
| Manufacturer | Janssen Canada Inc. |
| Sponsor | Janssen Canada Inc. |
| Submission Date | April 21, 2016 |
| Submission Deemed Complete | May 12, 2016 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | May 5, 2016 |
| Check-point meeting | July 8, 2016 |
| pERC Meeting | September 15, 2016 |
| Initial Recommendation Issued | September 29, 2016 |
| Feedback Deadline ‡ | October 14, 2016 |
| pERC Reconsideration Meeting | November 17, 2016 |
| Final Recommendation Issued | December 1, 2016 |
| Notification to Implement Issued | December 16, 2016 |
‡ 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.
