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| Project Number | pCODR 10058 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 50mg vial |
| Tumour Type | Skin and Melanoma |
| Indication | Metastatic Melanoma |
| Funding Request | For the treatment of patients with unresectable or metastatic melanoma |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | May 19, 2015 |
| Manufacturer | Merck Canada Inc. |
| Sponsor | Merck Canada Inc. |
| Submission Date | April 16, 2015 |
| Submission Deemed Complete | May 1, 2015 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | April 30, 2015 |
| Check-point meeting | June 15, 2015 |
| pERC Meeting | October 15, 2015 |
| Clarification | An expanded scope of review has been granted for pembrolizumab (Keytruda). In accordance with the pCODR Procedures, the pCODR Provincial Advisory Group (PAG) requested additional information on pembrolizumab (Keytruda) which extend beyond the submitted scope of the review. Revision of review scope may be considered by pCODR in very limited instances, based on jurisdictional input, feasibility to conduct the revised review and clinical importance. All three criteria for scope modification were met in this case. The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided and a new target pERC date has been set by pCODR. |
| Initial Recommendation Issued | October 29, 2015 |
| Feedback Deadline ‡ | November 12, 2015 |
| Final Recommendation Issued | November 16, 2015 |
| Notification to Implement Issued | December 1, 2015 |
‡ 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.
