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|Project Number||pCODR 10030|
|Strength||0.5 mg, 1.0 mg and 2.0 mg tablet|
|Tumour Type||Skin and 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|
|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.