| Project Number | pCODR 10147 |
|---|---|
| Brand Name | Opdivo |
| Generic Name | Nivolumab |
| Strength | 40 mg & 100 mg |
| Tumour Type | Skin & Melanoma |
| Indication | Melanoma Adjuvant Therapy |
| Funding Request | For the adjuvant treatment of adult patients after complete resection of melanoma with regional lymph node involvement, in transit metastases/satellites without metastatic nodes, or distant metastases |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | November 15, 2018 |
| Manufacturer | Bristol-Myers Squibb Canada |
| Submitter | Bristol-Myers Squibb Canada |
| Submission Date | August 27, 2018 |
| Submission Deemed Complete | September 11, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | September 11, 2018 |
| Check-point meeting | October 17, 2018 |
| pERC Meeting | December 13, 2018 |
| Initial Recommendation Issued | January 4, 2019 |
| Feedback Deadline ‡ | January 18, 2019 |
| pERC Reconsideration Meeting (target date) | February 21, 2019 |
| Final Recommendation Issued (target date) | March 7, 2019 |
| Notification to Implement Issued |
‡ 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.
