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Tafinlar & Mekinist in combo for Non-Small Cell Lung Cancer – Details

Project Number pCODR 10106
Brand Name Tafinlar & Mekinist in combo
Generic Name Dabrafenib & Trametinib in combo
Strength Dabrafenib: 50mg and 75mg capsules; Trametinib: 0.5mg and 2.0mg tablet
Tumour Type Lung
Indication Non-Small Cell Lung Cancer
Funding Request In combination for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation and who have been previously treated with chemotherapy
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date May 16, 2017
Manufacturer Novartis Pharmaceuticals Canada Inc.
Submitter Novartis Pharmaceuticals Canada Inc.
Submission Date March 31, 2017
Submission Deemed Complete April 7, 2017
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 17, 2017
Check-point meeting June 13, 2017
pERC Meeting August 17, 2017
Initial Recommendation Issued August 31, 2017
Feedback Deadline ‡ September 15, 2017
pERC Reconsideration Meeting October 19, 2017
Final Recommendation Issued November 2, 2017
Notification to Implement Issued November 17, 2017

‡ 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.