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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 Under Review
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 (target date) December 14, 2017
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.