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Opdivo for Non-Small Cell Lung Cancer – Details

Project Number PC0069-000
Brand Name Opdivo
Generic Name Nivolumab
Strength 40mg/4mL and 100mg/10mL vials
Tumour Type Lung
Indication Non-Small Cell Lung Cancer
Funding Request For the treatment of patients with advanced or metastatic non-small cell lung cancer who progressed on or after chemotherapy
Review Status Complete
Pre Noc Submission Yes
NOC Date February 26, 2016
Manufacturer Bristol-Myers Squibb Canada
Sponsor Bristol-Myers Squibb Canada
Submission Date October 29, 2015
Submission Deemed Complete November 5, 2015
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ November 12, 2015
Check-point meeting January 5, 2016
pERC Meeting March 17, 2016
Initial Recommendation Issued April 1, 2016
Feedback Deadline ‡ April 15, 2016
pERC Reconsideration Meeting May 19, 2016
Final Recommendation Issued June 3, 2016
Notification to Implement Issued June 20, 2016
Therapeutic Area Metastatic non small cell lung cancer
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.