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Keytruda for Non-Small Cell Lung Cancer (Second Line or Beyond) – Details

Project Number PC0077-000
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 50mg vial
Tumour Type Lung
Indication Non-Small Cell Lung Cancer (Second Line or Beyond)
Funding Request For the treatment of patients with metastatic NSCLC whose tumours express PD-L1 (as determined by a validated test) and who have disease progression on or after platinum-containing chemotherapy. Funding is being requested for patients with a TPS (Tumour Proportion Score) of PD-L1 ≥1%.
Review Status Complete
Pre Noc Submission No
NOC Date April 15, 2016
Manufacturer Merck Canada Inc.
Sponsor Merck Canada Inc.
Submission Date April 21, 2016
Submission Deemed Complete April 28, 2016
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ May 5, 2016
Check-point meeting June 9, 2016
pERC Meeting August 18, 2016
Initial Recommendation Issued September 1, 2016
Feedback Deadline ‡ September 16, 2016
pERC Reconsideration Meeting October 20, 2016
Final Recommendation Issued November 3, 2016
Notification to Implement Issued November 18, 2016
Therapeutic Area Non-Small Cell Lung Cancer
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.