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Stivarga Resubmission for mCRC - Details

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.
Submitter 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.