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Stivarga for Unresectable Hepatocellular Carcinoma (HCC) – Details

Project Number PC0119-000
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 Complete
Pre Noc Submission No
NOC Date September 18, 2017
Manufacturer Bayer Inc.
Sponsor Bayer Inc.
Submission Date October 12, 2017
Submission Deemed Complete October 19, 2017
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ October 26, 2017
Check-point meeting December 5, 2017
pERC Meeting March 15, 2018
Initial Recommendation Issued March 29, 2018
Feedback Deadline ‡ April 13, 2018
Final Recommendation Issued April 18, 2018
Notification to Implement Issued May 3, 2018
Therapeutic Area Unresectable Hepatocellular Carcinoma (HCC)
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.