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Opdivo for Metastatic Renal Cell Carcinoma – Details

Project Number PC0074-000
Brand Name Opdivo
Generic Name Nivolumab
Strength 40mg and 100mg vials
Tumour Type Genitourinary
Indication Metastatic Renal Cell Carcinoma
Funding Request For advanced or metastatic renal cell carcinoma in patients who have received prior systemic therapy
Review Status Complete
Pre Noc Submission Yes
NOC Date April 25, 2016
Manufacturer Bristol Myers-Squibb Canada
Sponsor Bristol Myers-Squibb Canada
Submission Date February 24, 2016
Submission Deemed Complete March 2, 2016
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ March 9, 2016
Check-point meeting April 15, 2016
pERC Meeting June 16, 2016
Initial Recommendation Issued June 30, 2016
Feedback Deadline ‡ July 15, 2016
pERC Reconsideration Meeting August 19, 2016
Clarification Please note that the August pERC meeting was conducted over two days. The original target date for the posting of pERC Final Recommendation remains as September 1, 2016.
Final Recommendation Issued September 1, 2016
Notification to Implement Issued September 19, 2016
Therapeutic Area Metastatic Renal Cell Carcinoma
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.