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Tafinlar & Mekinist in combo for Metastatic Melanoma - Details

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.
Submitter 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.