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| Project Number | pCODR 10120 |
|---|---|
| Brand Name | Opdivo |
| Generic Name | Nivolumab |
| Strength | 10 mg/mL |
| Tumour Type | Lymphoma |
| Indication | classical Hodgkin Lymphoma after failure of ASCT |
| Funding Request | For the treatment of adult patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous stem cell transplantation (ASCT) and brentuximab vedotin, or 3 or more lines of systemic therapy including ASCT |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | November 10, 2017 |
| Manufacturer | Bristol-Myers Squibb |
| Sponsor | Bristol-Myers Squibb |
| Submission Date | September 29, 2017 |
| Submission Deemed Complete | October 6, 2017 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | October 16, 2017 |
| Check-point meeting | November 20, 2017 |
| pERC Meeting | February 15, 2018 |
| Initial Recommendation Issued | March 2, 2018 |
| Feedback Deadline ‡ | March 16, 2018 |
| pERC Reconsideration Meeting | April 19, 2018 |
| Final Recommendation Issued | May 3, 2018 |
| Notification to Implement Issued | May 18, 2018 |
‡ 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.
