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|Project Number||pCODR 10185|
|Strength||25 mg/mL & 50 mg/vial|
|Indication||Renal Cell Carcinoma|
|Funding Request||For the treatment of patients with advanced renal cell carcinoma (RCC) in combination with axinitib, as first-line treatment.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||December 13, 2019|
|Submission Date||August 2, 2019|
|Submission Deemed Complete||August 19, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||August 19, 2019|
|Check-point meeting||October 30, 2019|
|pERC Meeting||January 16, 2020|
|Initial Recommendation Issued||January 30, 2020|
|Feedback Deadline ‡||February 13, 2020|
|pERC Reconsideration Meeting||March 19, 2020|
|Final Recommendation Issued||April 2, 2020|
|Notification to Implement Issued||April 20, 2020|
‡ 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.