| Project Number | pCODR 10106 |
|---|---|
| Brand Name | Tafinlar & Mekinist in combo |
| Generic Name | Dabrafenib & Trametinib in combo |
| Strength | Dabrafenib: 50mg and 75mg capsules; Trametinib: 0.5mg and 2.0mg tablet |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer |
| Funding Request | In combination for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation and who have been previously treated with chemotherapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | May 16, 2017 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | March 31, 2017 |
| Submission Deemed Complete | April 7, 2017 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | April 17, 2017 |
| Check-point meeting | June 13, 2017 |
| pERC Meeting | August 17, 2017 |
| Initial Recommendation Issued | August 31, 2017 |
| Feedback Deadline ‡ | September 15, 2017 |
| pERC Reconsideration Meeting | October 19, 2017 |
| Final Recommendation Issued | November 2, 2017 |
| Notification to Implement Issued | November 17, 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.
