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Tafinlar for Metastatic Melanoma - Details

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
Submitter 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.