| Project Number | pCODR 10053 |
|---|---|
| Brand Name | Tafinlar & Mekinist in combo |
| Generic Name | Dabrafenib & Trametinib in combo |
| Strength | Dabrafenib: 50mg and 75mg capsules;Trametinib: 0.5mg and 2.0mg tablets |
| Tumour Type | Skin and Melanoma |
| Indication | Metastatic Melanoma |
| Funding Request | Dabrafenib and trametinib in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF 600 mutation. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | March 6, 2015 |
| Manufacturer | GlaxoSmithKline Inc. |
| Sponsor | GlaxoSmithKline Inc. |
| Submission Date | February 13, 2015 |
| Submission Deemed Complete | February 23, 2015 |
| Submission Type | New Indication |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | March 2, 2015 |
| Check-point meeting | April 8, 2015 |
| pERC Meeting | June 18, 2015 |
| Initial Recommendation Issued | July 3, 2015 |
| Feedback Deadline ‡ | July 17, 2015 |
| Final Recommendation Issued | July 21, 2015 |
| Notification to Implement Issued | August 6, 2015 |
‡ 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.
