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| 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.
