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Opdivo for Squamous Cell Carcinoma of the Head and Neck (SCCHN) – Details

Project Number pCODR 10095
Brand Name Opdivo
Generic Name Nivolumab
Strength 40mg and 100mg single-use vials
Tumour Type Head and Neck
Indication Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Funding Request For the treatment of recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) after platinum-based therapy in adults
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date May 12, 2017
Manufacturer Bristol-Myers Squibb Canada
Submitter Bristol-Myers Squibb Canada
Submission Date January 31, 2017
Submission Deemed Complete February 13, 2017
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ February 14, 2017
Check-point meeting April 5, 2017
pERC Meeting June 15, 2017
Initial Recommendation Issued June 29, 2017
Feedback Deadline ‡ July 14, 2017
pERC Reconsideration Meeting August 17, 2017
Final Recommendation Issued August 31, 2017
Notification to Implement Issued September 18, 2017

‡ 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.