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Stivarga for Gastrointestinal Stromal Tumours - Details

Project Number PC0034-000
Brand Name Stivarga (GIST)
Generic Name Regorafenib
Strength 40 mg Tablets
Tumour Type Other
Indication Gastrointestinal Stromal Tumours
Funding Request Treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumours (GIST) who have had disease progression on or intolerance to imatinib mesylate, and sunitinib malate treatment
Review Status Complete
Pre Noc Submission No
NOC Date October 4, 2013
Manufacturer Bayer Inc.
Sponsor Bayer Inc.
Submission Date October 11, 2013
Submission Deemed Complete October 29, 2013
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ October 28, 2013
Check-point meeting (target date) December 3, 2013
pERC Meeting February 20, 2014
Initial Recommendation Issued March 6, 2014
Feedback Deadline ‡ March 20, 2014
pERC Reconsideration Meeting April 17, 2014
Final Recommendation Issued May 2, 2014
Notification to Implement Issued May 20, 2014
Therapeutic Area Gastrointestinal Stromal Tumour
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.