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Opdivo in combo with Yervoy for Renal Cell Carcinoma – Details

Project Number pCODR 10132
Brand Name Opdivo in combination with Yervoy
Generic Name Nivolumab in combination with Ipilimumab
Tumour Type Genitourinary
Indication Renal Cell Carcinoma
Funding Request Intermediate/poor risk patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC)
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Bristol-Myers Squibb
Submitter Bristol-Myers Squibb
Submission Date (Target Date) April 26, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ May 10, 2018
Check-point meeting (target date)
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.