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Keytruda for Metastatic Melanoma – Details

Project Number pCODR 10058
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 50mg vial
Tumour Type Skin and Melanoma
Indication Metastatic Melanoma
Funding Request For the treatment of patients with unresectable or metastatic melanoma
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date May 19, 2015
Manufacturer Merck Canada Inc.
Submitter Merck Canada Inc.
Submission Date April 16, 2015
Submission Deemed Complete May 1, 2015
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ April 30, 2015
Check-point meeting June 15, 2015
pERC Meeting October 15, 2015
Clarification An expanded scope of review has been granted for pembrolizumab (Keytruda). In accordance with the pCODR Procedures, the pCODR Provincial Advisory Group (PAG) requested additional information on pembrolizumab (Keytruda) which extend beyond the submitted scope of the review. Revision of review scope may be considered by pCODR in very limited instances, based on jurisdictional input, feasibility to conduct the revised review and clinical importance. All three criteria for scope modification were met in this case. The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided and a new target pERC date has been set by pCODR.
Initial Recommendation Issued October 29, 2015
Feedback Deadline ‡ November 12, 2015
Final Recommendation Issued November 16, 2015
Notification to Implement Issued December 1, 2015

‡ 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.