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Stivarga for Unresectable Hepatocellular Carcinoma (HCC) – Details

Project Number pCODR 10119
Brand Name Stivarga
Generic Name Regorafenib
Strength 40 mg
Tumour Type Gastrointestinal
Indication Unresectable Hepatocellular Carcinoma (HCC)
Funding Request For treatment of patients with unresectable hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Review Status Under Review
Pre Noc Submission No
NOC Date September 18, 2017
Manufacturer Bayer Inc.
Submitter Bayer Inc.
Submission Date October 12, 2017
Submission Deemed Complete October 19, 2017
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ October 26, 2017
Check-point meeting December 5, 2017
pERC Meeting (target date) March 15, 2018
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.