| Project Number | pCODR 10095 |
|---|---|
| Brand Name | Opdivo |
| Generic Name | Nivolumab |
| Strength | 40mg and 100mg single-use vials |
| Tumour Type | Head and Neck |
| Indication | Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
| Funding Request | For the treatment of recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) after platinum-based therapy in adults |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | May 12, 2017 |
| Manufacturer | Bristol-Myers Squibb Canada |
| Submitter | Bristol-Myers Squibb Canada |
| Submission Date | January 31, 2017 |
| Submission Deemed Complete | February 13, 2017 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | February 14, 2017 |
| Check-point meeting | April 5, 2017 |
| pERC Meeting | June 15, 2017 |
| Initial Recommendation Issued (target date) | June 29, 2017 |
| 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.