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| Project Number | pCODR 10216 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Tumour Type | Head and Neck |
| Indication | Head and Neck Squamous Cell Carcinoma (HNSCC) |
| Funding Request | For the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) as monotherapy or in combination with platinum and fluorouracil (FU) chemotherapy |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Merck Canada |
| Sponsor | Merck Canada |
| Submission Date | May 1, 2020 |
| Clarification | The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date has been provided. |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | May 15, 2020 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| 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.
