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Tafinlar & Mekinist in combo Melanoma Adjuvant Therapy – Details

Project Number pCODR 10152
Brand Name Tafinlar & Mekinist in combo
Generic Name Dabrafenib & Trametinib in combo
Strength 50 mg & 75 mg and 0.5 mg & 2.0 mg
Tumour Type Skin & Melanoma
Indication Melanoma Adjuvant Therapy
Funding Request For the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date September 21, 2018
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date September 21, 2018
Submission Deemed Complete October 5, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 5, 2018
Check-point meeting November 14, 2018
pERC Meeting February 21, 2019
Initial Recommendation Issued March 7, 2019
Feedback Deadline ‡ March 21, 2019
pERC Reconsideration Meeting April 18, 2019
Final Recommendation Issued May 3, 2019
Notification to Implement Issued May 21, 2019

‡ 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.