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Opdivo in combo with Yervoy for Renal Cell Carcinoma – Details

Project Number PC0132-000
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 Complete
Pre Noc Submission Yes
NOC Date July 6, 2018
Manufacturer Bristol-Myers Squibb
Sponsor Bristol-Myers Squibb
Submission Date April 26, 2018
Submission Deemed Complete May 3, 2018
Submission Type Initial
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
Therapeutic Area Advanced or Metastatic Renal Cell Carcinoma (RCC).
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.