NEXAVAR
Nexavar (sorafenib tosylate) is a kinase inhibitor indicated for the treatment of specific types of liver, kidney, and thyroid cancers. It is used for patients with unresectable hepatocellular carcinoma and those with advanced renal cell carcinoma. The medication is also approved for patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.
How NEXAVAR Works
Sorafenib acts by inhibiting multiple intracellular and cell surface kinases, including RAF, VEGFR, and PDGFR. These kinases are involved in critical biological processes such as tumor cell signaling, the development of new blood vessels, and programmed cell death. By blocking these targets, the drug decreases tumor cell proliferation and reduces tumor angiogenesis to inhibit cancer growth.
Details
- Status
- Prescription
- First Approved
- 2005-12-01
- Routes
- ORAL
- Dosage Forms
- TABLET
NEXAVAR Approval History
What NEXAVAR Treats
3 indicationsNEXAVAR is approved for 3 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable hepatocellular carcinoma
- Advanced renal cell carcinoma
- Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment
NEXAVAR Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
NEXAVAR Competitors
Pro2 other drugs also target VEGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (VEGFR). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to NEXAVAR
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEXAVAR FDA Label Details
ProIndications & Usage
FDA Label (PDF)NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma • Advanced renal cell carcinoma • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma NEXAVAR is indicated for the treatment of patients...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.