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Keytruda for Melanoma Adjuvant Treatment – Details

Project Number pCODR 10168
Brand Name Keytruda
Generic Name Pembrolizumab
Tumour Type Skin & Melanoma
Indication Melanoma Adjuvant Treatment
Funding Request For adjuvant treatment of Stage III melanoma  patients following resection ; for re-treatment of patients upon loco-regional or distant recurrence more than 6 months following completed adjuvant course of KEYTRUDA®
Review Status Pending
Pre Noc Submission
NOC Date
Manufacturer Merck Canada
Submitter Merck Canada
Submission Date (Target Date) December 7, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ December 21, 2018
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.