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|Project Number||pCODR 10132|
|Brand Name||Opdivo in combination with Yervoy|
|Generic Name||Nivolumab in combination with Ipilimumab|
|Indication||Renal Cell Carcinoma|
|Funding Request||Intermediate/poor risk patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC)|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||July 6, 2018|
|Submission Date||April 26, 2018|
|Submission Deemed Complete||May 3, 2018|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||May 10, 2018|
|Check-point meeting||June 20, 2018|
|pERC Meeting||August 16, 2018|
|Initial Recommendation Issued||August 30, 2018|
|Feedback Deadline ‡||September 14, 2018|
|pERC Reconsideration Meeting||October 18, 2018|
|Final Recommendation Issued||November 1, 2018|
|Notification to Implement Issued||November 16, 2018|
‡ 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.