| Project Number | pCODR 10168 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 25 mg / mL and 50 mg / vial |
| Tumour Type | Skin & Melanoma |
| Indication | Melanoma Adjuvant Treatment |
| Funding Request | For adjuvant treatment of Stage III melanoma patients following resection ; for re-treatment of patients upon loco-regional or distant recurrence more than 6 months following completed adjuvant course of KEYTRUDA® |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | April 2, 2019 |
| Manufacturer | Merck Canada |
| Submitter | Merck Canada |
| Submission Date | December 13, 2018 |
| Submission Deemed Complete | January 15, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | January 4, 2019 |
| Check-point meeting | February 26, 2019 |
| pERC Meeting | May 16, 2019 |
| Initial Recommendation Issued (target date) | May 31, 2019 |
| Feedback Deadline (target date) ‡ | June 14, 2019 |
| 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.