| Project Number | pCODR 10147 |
|---|---|
| Brand Name | Opdivo |
| Generic Name | Nivolumab |
| Tumour Type | Skin & Melanoma |
| Indication | Melanoma Adjuvant Therapy |
| Funding Request | For the use of nivolumab for the adjuvant treatment of patients with completely resected Stage III and IV melanoma |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | |
| 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 (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued (target date) | |
| 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.