Stivarga for Gastrointestinal Stromal Tumours - Details

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Generic Name:
Regorafenib
Project Status:
Complete
Therapeutic Area:
Gastrointestinal Stromal Tumour
Manufacturer:
Bayer Inc.
Brand Name:
Stivarga (GIST)
Project Line:
Reimbursement Review
Project Number:
PC0034-000
Strength:
40 mg Tablets
Tumour Type:
Other
Indications:
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
Sponsor:
Bayer Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting (target date):
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

‡ 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.