| Project Number | pCODR 10152 |
|---|---|
| Brand Name | Tafinlar & Mekinist in combo |
| Generic Name | Dabrafenib & Trametinib in combo |
| Strength | 50 mg & 75 mg and 0.5 mg & 2.0 mg |
| Tumour Type | Skin & Melanoma |
| Indication | Melanoma Adjuvant Therapy |
| Funding Request | For the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | September 21, 2018 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Submitter | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | September 21, 2018 |
| Submission Deemed Complete | October 5, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 5, 2018 |
| Check-point meeting | November 14, 2018 |
| pERC Meeting (target date) | February 21, 2019 |
| 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.