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| 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 | Notification to Implement Issued |
| 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 | November 19, 2020 |
| Initial Recommendation Issued | December 3, 2020 |
| Feedback Deadline ‡ | December 17, 2020 |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued | December 22, 2020 |
| Notification to Implement Issued | January 14, 2021 |
‡ 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.
