| Project Number | pCODR 10177 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 25 mg/mL |
| 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 | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | April 11, 2019 |
| Manufacturer | Merck Canada |
| Sponsor | Merck Canada |
| Submission Date | February 20, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | March 6, 2019 |
| Check-point meeting (target date) | April 23, 2019 |
| pERC Meeting | July 18, 2019 |
| Initial Recommendation Issued | August 1, 2019 |
| Feedback Deadline ‡ | August 16, 2019 |
| pERC Reconsideration Meeting | September 19, 2019 |
| Final Recommendation Issued | October 3, 2019 |
| Notification to Implement Issued | October 21, 2019 |
‡ 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.
