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|Project Number||pCODR 10026|
|Brand Name||Stivarga (CRC)|
|Strength||40 mg tablets|
|Indication||Metastatic Colorectal Cancer|
|Funding Request||The treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||March 11, 2013|
|Submission Date||March 22, 2013|
|Submission Deemed Complete||April 8, 2013|
|Submission Type||New Drug|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||April 9, 2013|
|Check-point meeting||July 3, 2013|
|pERC Meeting||August 15, 2013|
|Initial Recommendation Issued||August 29, 2013|
|Feedback Deadline ‡||September 13, 2013|
|pERC Reconsideration Meeting||October 31, 2013|
|Final Recommendation Issued||November 15, 2013|
|Notification to Implement Issued||December 2, 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.