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Stivarga for Metastatic Colorectal Cancer - Details

Project Number pCODR 10026
Brand Name Stivarga (CRC)
Generic Name Regorafenib
Strength 40 mg tablets
Tumour Type Gastrointestinal
Indication Metastatic Colorectal Cancer
Funding Request The treatment of patients with metastatic colorectal cancer (CRC) 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 March 22, 2013
Submission Deemed Complete April 8, 2013
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 9, 2013
Check-point meeting July 3, 2013
pERC Meeting August 15, 2013
Initial Recommendation Issued August 29, 2013
Feedback Deadline ‡ September 13, 2013
pERC Reconsideration Meeting October 31, 2013
Final Recommendation Issued November 15, 2013
Notification to Implement Issued December 2, 2013

‡ 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.