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Opdivo for Hepatocellular Carcinoma (HCC) – Details

Project Number pCODR 10134
Brand Name Opdivo
Generic Name Nivolumab
Tumour Type Gastrointestinal
Indication Hepatocellular Carcinoma (HCC)
Funding Request For the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic hepatocellular carcinoma that are intolerant to or have progressed on sorafenib therapy
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Bristol-Myers Squibb Canada
Submitter Bristol-Myers Squibb Canada
Submission Date (Target Date) May 8, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ May 23, 2018
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
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.