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Keytruda for Advanced Non-Small Cell Lung Carcinoma (First Line) – Details

Project Number pCODR 10101
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 50mg vial
Tumour Type Lung
Indication Non-Small Cell Lung Carcinoma (First Line)
Funding Request For previously untreated patients with metastatic NSCLC whose tumours express PD-L1 and who do not harbor a sensitizing EGFR mutation or ALK translocation. Funding is being requested for patients with a TPS (Tumour Proportion Score) of PD-L1 ≥50%.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 12, 2017
Manufacturer Merck Canada Inc.
Submitter Merck Canada Inc.
Submission Date December 12, 2016
Submission Deemed Complete December 19, 2016
Submission Type New Indication
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ January 3, 2017
Check-point meeting February 15, 2017
pERC Meeting July 20, 2017
Clarification The Manufacturer has advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting has been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements.
Initial Recommendation Issued August 3, 2017
Feedback Deadline ‡ August 18, 2017
Final Recommendation Issued August 23, 2017
Notification to Implement Issued September 8, 2017

‡ 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.