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Keytruda for Squamous NSCLC – Details

Project Number pCODR 10176
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 50 mg/vial & 25 mg/mL
Tumour Type Lung
Indication Squamous NSCLC
Funding Request For the treatment of patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel, in adults with no prior systemic chemotherapy treatment for metastatic NSCLC
Review Status Open for Feedback on Recommendation
Pre Noc Submission Yes
NOC Date July 4, 2019
Manufacturer Merck Canada
Sponsor Merck Canada
Submission Date February 8, 2019
Submission Deemed Complete February 25, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ February 25, 2019
Check-point meeting May 21, 2019
pERC Meeting October 17, 2019
Clarification The pCODR Expert Review Committee (pERC) Recommendation was deferred on September 19, 2019 pending additional information from the review team.
Initial Recommendation Issued October 31, 2019
Feedback Deadline ‡ November 14, 2019
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.