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Keytruda Metastatic Urothelial Carcinoma (first line) – Details

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.