| Project Number | pCODR 10177 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Tumour Type | Genitourinary |
| Indication | Metastatic Urothelial Carcinoma (first line) |
| Funding Request | For the treatment of patients with locally advanced or metastatic urothelial carcinoma, as monotherapy, in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD‑L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, or in patients who are not eligible for any platinum‑containing chemotherapy regardless of PD‑L1 status |
| Review Status | Pending |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Merck Canada |
| Submitter | Merck Canada |
| Submission Date (Target Date) | February 20, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | March 6, 2019 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| Initial Recommendation Issued (target date) | |
| Feedback Deadline (target date) ‡ | |
| 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.
