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| Project Number | pCODR 10074 |
|---|---|
| Brand Name | Opdivo |
| Generic Name | Nivolumab |
| Strength | 40mg and 100mg vials |
| Tumour Type | Genitourinary |
| Indication | Metastatic Renal Cell Carcinoma |
| Funding Request | For advanced or metastatic renal cell carcinoma in patients who have received prior systemic therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | April 25, 2016 |
| Manufacturer | Bristol Myers-Squibb Canada |
| Sponsor | Bristol Myers-Squibb Canada |
| Submission Date | February 24, 2016 |
| Submission Deemed Complete | March 2, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | March 9, 2016 |
| Check-point meeting | April 15, 2016 |
| pERC Meeting | June 16, 2016 |
| Initial Recommendation Issued | June 30, 2016 |
| Feedback Deadline ‡ | July 15, 2016 |
| pERC Reconsideration Meeting | August 19, 2016 |
| Clarification | Please note that the August pERC meeting was conducted over two days. The original target date for the posting of pERC Final Recommendation remains as September 1, 2016. |
| Final Recommendation Issued | September 1, 2016 |
| Notification to Implement Issued | September 19, 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.
