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Keytruda for Melanoma Adjuvant Treatment – Details

Project Number PC0168-000
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 25 mg / mL and 50 mg / vial
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 Complete
Pre Noc Submission Yes
NOC Date April 2, 2019
Manufacturer Merck Canada
Sponsor Merck Canada
Submission Date December 13, 2018
Submission Deemed Complete January 15, 2019
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ January 4, 2019
Check-point meeting February 26, 2019
pERC Meeting May 16, 2019
Initial Recommendation Issued May 31, 2019
Feedback Deadline ‡ June 14, 2019
pERC Reconsideration Meeting July 18, 2019
Final Recommendation Issued August 1, 2019
Notification to Implement Issued August 19, 2019
Therapeutic Area Melanoma Adjuvant Treatment
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.