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| Project Number | pCODR 10226 |
|---|---|
| Brand Name | Tafinlar and Mekinist |
| Generic Name | Dabrafenib and Trametinib |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer (NSCLC) BRAF V600 mutation |
| Funding Request | For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation and who have not received any prior anti-cancer therapy for metastatic disease. |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | October 1, 2020 |
| Submission Deemed Complete | October 16, 2020 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 16, 2020 |
| Check-point meeting | January 11, 2021 |
| 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.