| Project Number | pCODR 10117 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 50 mg/vial |
| Tumour Type | Genitourinary |
| Indication | Metastatic Urothelial Carcinoma |
| Funding Request | For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum-containing chemotherapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | September 20, 2017 |
| Manufacturer | Merck Canada Inc. |
| Sponsor | Merck Canada Inc. |
| Submission Date | July 24, 2017 |
| Submission Deemed Complete | July 31, 2017 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | August 8, 2017 |
| Check-point meeting | September 19, 2017 |
| pERC Meeting | December 14, 2017 |
| Initial Recommendation Issued | January 5, 2018 |
| Feedback Deadline ‡ | January 19, 2018 |
| pERC Reconsideration Meeting | February 15, 2018 |
| Final Recommendation Issued | March 2, 2018 |
| Notification to Implement Issued | March 19, 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.
