Last Updated : September 29, 2015
Details
FilesGeneric Name:
Regorafenib
Project Status:
Complete
Therapeutic Area:
Metastatic Colorectal Cancer
Manufacturer:
Bayer Inc.
Brand Name:
Stivarga Resubmission (CRC)
Project Line:
Reimbursement Review
Project Number:
PC0046-000
Strength:
40mg tablet
Tumour Type:
Gastrointestinal
Indications:
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:
Complete
Sponsor:
Bayer Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
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.
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
pERC Meeting:
pERC Meeting (target date):
Final Recommendation Issued:
Files
‡ 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.
Last Updated : September 29, 2015