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Dabrafenib and Trametinib for Non-Small Cell Lung Cancer BRAF V600 Mutation - Details

Project Number pCODR 10226
Brand Name Tafinlar and Mekinist
Generic Name Dabrafenib and Trametinib
Tumour Type Lung
Indication Non-Small Cell Lung Cancer (NSCLC) BRAF V600 mutation
Funding Request For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation and who have not received any prior anti-cancer therapy for metastatic disease.
Review Status Under Review
Pre Noc Submission No
NOC Date
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date October 1, 2020
Submission Deemed Complete October 16, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 16, 2020
Check-point meeting January 11, 2021
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.