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|Project Number||pCODR 10123|
|Indication||Renal Cell Carcinoma (RCC)|
|Funding Request||For the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior therapy|
|Pre Noc Submission||Yes|
|Manufacturer||Ipsen Biopharmaceuticals Canada Inc.|
|Sponsor||Ipsen Biopharmaceuticals Canada Inc.|
|Clarification||Ipsen Biopharmaceuticals Canada Inc. has notified pCODR that the Category 2 submission requirements for the pre NOC submission of Cabozantinib (Cabometyx) RCC cannot be met at this time. As per pCODR Procedures C3.1.6, the pCODR program has stopped the review.|
|Submission Date||October 6, 2017|
|Submission Deemed Complete||October 16, 2017|
|Submission Type||New Drug|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||October 23, 2017|
|Check-point meeting||November 27, 2017|
|pERC Meeting (target date)|
|Initial Recommendation Issued (target date)|
|Feedback Deadline (target date) ‡|
|pERC Reconsideration Meeting (target date)|
|Final Recommendation Issued (target date)|
|Notification to Implement Issued|
‡ 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.