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Keytruda for Non-Squamous NSCLC – Details

Project Number pCODR 10153
Brand Name Keytruda
Generic Name Pembrolizumab
Tumour Type Lung
Indication Non-Squamous NSCLC
Funding Request In combination with pemetrexed and platinum chemotherapy, for the treatment of metastatic non-squamous NSCLC, in adults with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Merck Canada
Submitter Merck Canada
Submission Date September 14, 2018
Submission Deemed Complete September 28, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ September 28, 2018
Check-point meeting (target date) December 11, 2018
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.