| Project Number | pCODR 10025 |
|---|---|
| Brand Name | Tafinlar |
| Generic Name | Dabrafenib |
| Strength | 50 mg and 75 mg capsule |
| Tumour Type | Skin and Melanoma |
| Indication | Metastatic Melanoma |
| Funding Request | For use as monotherapy for the treatment of patients with unresectable or metastatic melanoma, with a BRAF V600 mutation |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | July 16, 2013 |
| Manufacturer | GlaxoSmithKline |
| Sponsor | GlaxoSmithKline |
| Submission Date | March 18, 2013 |
| Submission Deemed Complete | March 28, 2013 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | April 3, 2013 |
| Check-point meeting | June 24, 2013 |
| pERC Meeting | September 19, 2013 |
| Initial Recommendation Issued | October 3, 2013 |
| Feedback Deadline ‡ | October 18, 2013 |
| pERC Reconsideration Meeting | November 21, 2013 |
| Final Recommendation Issued | December 5, 2013 |
| Notification to Implement Issued | December 20, 2013 |
| Clarification | A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline. |
‡ 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.
