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Pembrolizumab (Keytruda) for Renal Cell Carcinoma — Details

Project Number pCODR 10185
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 25 mg/mL & 50 mg/vial
Tumour Type Genitourinary
Indication Renal Cell Carcinoma
Funding Request For the treatment of patients with advanced renal cell carcinoma (RCC) in combination with axinitib, as first-line treatment.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date December 13, 2019
Manufacturer Merck Canada
Sponsor Merck Canada
Submission Date August 2, 2019
Submission Deemed Complete August 19, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ August 19, 2019
Check-point meeting October 30, 2019
pERC Meeting January 16, 2020
Initial Recommendation Issued January 30, 2020
Feedback Deadline ‡ February 13, 2020
pERC Reconsideration Meeting March 19, 2020
Final Recommendation Issued April 2, 2020
Notification to Implement Issued April 20, 2020

‡ 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.