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| Project Number | pCODR 10077 |
|---|---|
| Brand Name | Keytruda |
| Generic Name | Pembrolizumab |
| Strength | 50mg vial |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer (Second Line or Beyond) |
| Funding Request | For the treatment of patients with metastatic NSCLC whose tumours express PD-L1 (as determined by a validated test) and who have disease progression on or after platinum-containing chemotherapy. Funding is being requested for patients with a TPS (Tumour Proportion Score) of PD-L1 ≥1%. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | April 15, 2016 |
| Manufacturer | Merck Canada Inc. |
| Sponsor | Merck Canada Inc. |
| Submission Date | April 21, 2016 |
| Submission Deemed Complete | April 28, 2016 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | May 5, 2016 |
| Check-point meeting | June 9, 2016 |
| pERC Meeting | August 18, 2016 |
| Initial Recommendation Issued | September 1, 2016 |
| Feedback Deadline ‡ | September 16, 2016 |
| pERC Reconsideration Meeting | October 20, 2016 |
| Final Recommendation Issued | November 3, 2016 |
| Notification to Implement Issued | November 18, 2016 |
‡ 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.
