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Cotellic for Metastatic Melanoma – Details

Project Number pCODR 10070
Brand Name Cotellic
Generic Name Cobimetinib
Strength 20 mg tablet
Tumour Type Skin and Melanoma
Indication Metastatic Melanoma
Funding Request In combination vermurafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date February 22, 2016
Manufacturer Hoffmann-la Roche Ltd.
Submitter Hoffmann-la Roche Ltd.
Submission Date December 11, 2015
Submission Deemed Complete December 18, 2015
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ January 4, 2016
Check-point meeting February 9, 2016
pERC Meeting April 22, 2016
Initial Recommendation Issued May 5, 2016
Feedback Deadline ‡ May 19, 2016
pERC Reconsideration Meeting June 16, 2016
Final Recommendation Issued June 30, 2016
Notification to Implement Issued July 18, 2016

‡ 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.