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|Project Number||pCODR 10090|
|Strength||100 mg and 300 mg tablets|
|Indication||Medullary Thyroid Cancer|
|Funding Request||For the treatment of symptomatic and/or progressive medullary thyroid cancer in adult patients with unresectable locally advanced or metastatic disease|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||January 12, 2012|
|Submission Date||August 15, 2016|
|Submission Deemed Complete||August 22, 2016|
|Submission Type||New Drug|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||August 29, 2016|
|Check-point meeting||October 17, 2016|
|pERC Meeting||January 19, 2017|
|Initial Recommendation Issued||February 2, 2017|
|Feedback Deadline ‡||February 16, 2017|
|pERC Reconsideration Meeting||March 16, 2017|
|Final Recommendation Issued||March 30, 2017|
|Notification to Implement Issued||April 17, 2017|
‡ 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.