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Mekinist for Metastatic Melanoma - Details

Project Number pCODR 10030
Brand Name Mekinist
Generic Name Trametinib
Strength 0.5 mg, 1.0 mg and 2.0 mg tablet
Tumour Type Skin and Melanoma
Indication Metastatic Melanoma
Funding Request For use as a 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 18, 2013
Manufacturer GlaxoSmithKline
Submitter GlaxoSmithKline
Submission Date May 6, 2013
Submission Deemed Complete May 14, 2013
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 21, 2013
Check-point meeting July 30, 2013
pERC Meeting September 19, 2013
Initial Recommendation Issued October 3, 2013
Feedback Deadline ‡ October 18, 2013
pERC Reconsideration Meeting (target date)
Final Recommendation Issued October 22, 2013
Notification to Implement Issued November 6, 2013

‡ 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.