| Project Number | pCODR 10046 |
|---|---|
| Brand Name | Stivarga Resubmission (CRC) |
| Generic Name | Regorafenib |
| Strength | 40mg tablet |
| Tumour Type | Gastrointestinal |
| Indication | Metastatic Colorectal Cancer |
| Funding Request | Treatment of patients with metastatic colorectal cancer (CRC), and an ECOG status of ≤1, who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | March 11, 2013 |
| Manufacturer | Bayer Inc. |
| Sponsor | Bayer Inc. |
| Submission Date | December 19, 2014 |
| Submission Deemed Complete | January 12, 2015 |
| Submission Type | Resubmission |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | January 12, 2015 |
| Check-point meeting | March 2, 2015 |
| pERC Meeting | April 17, 2015 |
| Initial Recommendation Issued | April 30, 2015 |
| Clarification | Please note that the April pERC meeting was conducted over two days. The original date for the posting of pERC Initial Recommendation remained as April 30, 2015. |
| Feedback Deadline ‡ | May 14, 2015 |
| pERC Reconsideration Meeting | July 2, 2015 |
| Clarification | Due to the number of items for deliberation, the pERC meeting was conducted over two days. Unable to reach quorum for either day around the target reconsideration meeting date of June 18, 2015, pERC held deliberations for all reconsideration items, including the regorafenib resubmission, on July 2, 2015 |
| Final Recommendation Issued | July 16, 2015 |
| Notification to Implement Issued | July 31, 2015 |
‡ 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.
