This is a summary of the European public assessment report (EPAR) for Stivarga. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Stivarga. For practical information about using Stivarga, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Stivarga is indicated as monotherapy for the treatment of adult patients with: - metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; - unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; - hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Therapeutic Area (MeSH)
N/AATC Code
L01EX05
ATC Item
regorafenib
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| regorafenib | N/A | 瑞戈非尼 |
EMA Name
Stivarga
Medicine Name
Stivarga
Aliases
N/ANo risk management plan link.
