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Keytruda for Metastatic Urothelial Carcinoma – Details

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.
Submitter 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.