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Stivarga for Unresectable Hepatocellular Carcinoma (HCC) – Details

Project Number pCODR 10119
Brand Name Stivarga
Generic Name Regorafenib
Tumour Type Gastrointestinal
Indication Unresectable Hepatocellular Carcinoma (HCC)
Funding Request For treatment of of patients with unresectable hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Bayer Inc.
Submitter Bayer Inc.
Submission Date (Target Date) October 12, 2017
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ October 26, 2017
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.