| Project Number | pCODR 10109 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 50 mg/vial |
| Tumour Type | Lymphoma |
| Indication | classical Hodgkin Lymphoma (cHL) |
| Funding Request | As monotherapy is indicated for the treatment of adult patients with refractory or relapsed classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) or who are not ASCT candidates and have failed BV |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | |
| NOC/c Date | September 8, 2017 |
| Manufacturer | Merck Canada Inc. |
| Sponsor | Merck Canada Inc. |
| Submission Date | July 7, 2017 |
| Submission Deemed Complete | July 14, 2017 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | July 21, 2017 |
| Check-point meeting | September 6, 2017 |
| pERC Meeting | October 19, 2017 |
| Initial Recommendation Issued | November 2, 2017 |
| Feedback Deadline ‡ | November 16, 2017 |
| pERC Reconsideration Meeting | December 14, 2017 |
| Final Recommendation Issued | January 5, 2018 |
| Notification to Implement Issued | January 22, 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.
