| Project Number | pCODR 10069 |
|---|---|
| Brand Name | Opdivo |
| Generic Name | Nivolumab |
| Strength | 40mg/4mL and 100mg/10mL vials |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer |
| Funding Request | For the treatment of patients with advanced or metastatic non-small cell lung cancer who progressed on or after chemotherapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | February 26, 2016 |
| Manufacturer | Bristol-Myers Squibb Canada |
| Sponsor | Bristol-Myers Squibb Canada |
| Submission Date | October 29, 2015 |
| Submission Deemed Complete | November 5, 2015 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | November 12, 2015 |
| Check-point meeting | January 5, 2016 |
| pERC Meeting | March 17, 2016 |
| Initial Recommendation Issued | April 1, 2016 |
| Feedback Deadline ‡ | April 15, 2016 |
| pERC Reconsideration Meeting | May 19, 2016 |
| Final Recommendation Issued | June 3, 2016 |
| Notification to Implement Issued | June 20, 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.
