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Keytruda for Non-Squamous NSCLC – Details

Project Number PC0153-000
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 25 mg/mL & 50 mg/vial
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 Complete
Pre Noc Submission Yes
NOC Date March 13, 2019
Manufacturer Merck Canada
Sponsor Merck Canada
Submission Date September 14, 2018
Submission Deemed Complete September 28, 2018
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ September 28, 2018
Check-point meeting December 11, 2018
pERC Meeting March 21, 2019
Initial Recommendation Issued April 4, 2019
Feedback Deadline ‡ April 18, 2019
pERC Reconsideration Meeting May 16, 2019
Final Recommendation Issued May 31, 2019
Notification to Implement Issued June 17, 2019
Therapeutic Area Nonsquamous NSCLC
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.