Stivarga (regorafenib)
- Region
- 🇪🇺 EU
- Active substance
- regorafenib
- Company
- Bayer Pharma AG
- Status
- Authorised
- Therapeutic area
- Colorectal Neoplasms
- EU approval
- Mon 26 Aug 2013
- Application
- EMEA/H/C/002573
- ATC
- L01EX05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.