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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
Strength 10 mg/mL
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 Under Review
Pre Noc Submission Yes
NOC Date July 6, 2018
Manufacturer Bristol-Myers Squibb
Submitter Bristol-Myers Squibb
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 (target date) October 18, 2018
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.