Begin main content

Opdivo for Hepatocellular Carcinoma – Details

Project Number pCODR 10134
Brand Name Opdivo
Generic Name Nivolumab
Strength 10 mg/mL
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 who are intolerant to or have progressed on sorafenib therapy
Review Status Under Review
Pre Noc Submission No
NOC Date March 23, 2018
Manufacturer Bristol-Myers Squibb Canada
Submitter Bristol-Myers Squibb Canada
Submission Date May 8, 2018
Submission Deemed Complete May 15, 2018
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 23, 2018
Check-point meeting July 10, 2018
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.