Stivarga
Stivarga ingredients
| Active ingredient | Strength |
|---|---|
| Regorafenib | 40 mg/1 |
What Stivarga is used for
The FDA lists the approved uses on the official label (below). In the EU, regorafenib is approved as Stivarga for:
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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Stivarga
- Generic name
- Regorafenib
- Made by
- Bayer HealthCare Pharmaceuticals Inc.
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA203085
- On the US market since
- 2012
Official information
- Stivarga prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Regorafenib)
In India
- Regorafenib: 2 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Stivarga?
Stivarga (Regorafenib) is a cancer medicine made by Bayer HealthCare Pharmaceuticals Inc., approved by the US FDA.
What are the ingredients of Stivarga?
Stivarga contains Regorafenib (40 mg/1).
Is Stivarga approved in Europe?
The same active substance is approved in the EU as Stivarga.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA