| Project Number | pCODR 10101 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 50mg vial |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Carcinoma (First Line) |
| Funding Request | For previously untreated patients with metastatic NSCLC whose tumours express PD-L1 and who do not harbor a sensitizing EGFR mutation or ALK translocation. Funding is being requested for patients with a TPS (Tumour Proportion Score) of PD-L1 ≥50%. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | July 12, 2017 |
| Manufacturer | Merck Canada Inc. |
| Sponsor | Merck Canada Inc. |
| Submission Date | December 12, 2016 |
| Submission Deemed Complete | December 19, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | January 3, 2017 |
| Check-point meeting | February 15, 2017 |
| pERC Meeting | July 20, 2017 |
| Clarification | The Manufacturer has advised that Category 2 submission requirements for a pre-NOC submission will not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting has been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements. |
| Initial Recommendation Issued | August 3, 2017 |
| Feedback Deadline ‡ | August 18, 2017 |
| Final Recommendation Issued | August 23, 2017 |
| Notification to Implement Issued | September 8, 2017 |
‡ 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.
