STIVARGA
PeakNDAORALTABLETPriority Review
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
STIVARGA by Bayer is membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. Approved for oxaliplatin-, irinotecan-based chemotherapy, an anti-vegf therapy and 5 more indications. First approved in 2013.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STIVARGA (regorafenib) is an oral small-molecule multi-kinase inhibitor that targets membrane-bound and intracellular kinases involved in tumor growth, angiogenesis, and metastasis. It is indicated for metastatic colorectal cancer (after prior chemotherapy and anti-VEGF therapy), unresectable or metastatic gastrointestinal stromal tumor (GIST) after sunitinib failure, and hepatocellular carcinoma. The drug works by inhibiting VEGFR, KIT, PDGFR, FGFR, RAF, and other kinases to suppress tumor angiogenesis and growth.
Peak
Product at peak maturity with moderate competitive pressure (30/100) suggests stable but not expanding commercial infrastructure.
Mechanism of Action
membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the…
Indications (8)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.