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Pembrolizumab (Keytruda) for HNSCC - Details

Project Number pCODR 10216
Brand Name Keytruda
Generic Name Pembrolizumab
Strength 25 mg/mL
Tumour Type Head and Neck
Indication Head and Neck Squamous Cell Carcinoma (HNSCC)
Funding Request First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression [Combined Positive Score (CPS) ≥ 1] as determined by a validated test. First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) chemotherapy, in adult patients.
Review Status Under Review
Pre Noc Submission Yes
NOC Date October 9, 2020
Manufacturer Merck Canada
Sponsor Merck Canada
Submission Date May 1, 2020
Submission Deemed Complete June 11, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ May 15, 2020
Check-point meeting August 11, 2020
pERC Meeting (target date) November 19, 2020
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.