NewsResearch
FDA Approval: Sorafenib (Nexavar) for Liver Cancer
FDA approved Sorafenib (Nexavar), a multikinase inhibitor, for certain people with liver cancer. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Historical context: this page explains an event dated 2007. It was published as an explainer on July 12, 2026 and is not breaking news.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
A kidney cancer drug that changed liver cancer
Sorafenib, sold as Nexavar, is a kinase inhibitor. Its FDA label states Initial U.S. Approval: 2005, which was for advanced renal cell carcinoma.
The liver cancer indication came later. The 2007 prescribing information lists, under Recent Major Changes, "Indication and Usage, Hepatocellular Carcinoma" dated 11/2007. From that point the label covered two cancers: unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Unresectable means the tumor cannot be removed by surgery. That word matters. Surgery and transplant are the routes to cure in liver cancer. An indication written for unresectable disease is aimed at people for whom those routes are closed.
NCI now also lists sorafenib for certain thyroid cancers. Those are cancers that grew, came back, or spread, and did not respond to radioactive iodine.
How it is taken
The label dose is 400 mg, two 200 mg tablets, by mouth twice daily, without food. That is the label figure. The prescription you are handed is what to follow, and it is often lowered for side effects.
Read that as the licensed reference. Your own liver or oncology team sets your amount and the timing around meals.
Treatment interruption or dose reduction may be needed to manage side effects. The label also describes two smaller steps down for people who cannot tolerate the full amount.
Two practical instructions sit in the same document. Stopping the drug for a time is advised around major surgery. And caution is advised when it is combined with docetaxel or doxorubicin.
What hepatocellular carcinoma is, and where it comes from
Hepatocellular carcinoma, or HCC, is the most common liver cancer in adults. NCI states that it typically develops in people with chronic liver disease caused by hepatitis virus infection or cirrhosis. Men are more likely to develop it than women.
Cirrhosis is the condition in which healthy liver tissue is replaced by scar tissue. That scarring blocks blood flow through the liver and stops it working properly. Chronic alcohol use and chronic hepatitis infections are common causes.
NCI's risk list is specific about geography and cause:
- Hepatitis B virus. Spread in blood, semen, and other body fluids. It can pass from mother to child at birth. Chronic HBV is the leading cause of liver cancer in Asia and Africa. Routine infant vaccination is cutting new infections.
- Hepatitis C virus. Spread in blood, mostly by shared needles. Chronic HCV is the leading cause of liver cancer in North America, Europe, and Japan. Blood banks now test all donated blood for it.
- Cirrhosis. People whose cirrhosis came from hepatitis C have a higher risk than those whose cirrhosis came from hepatitis B or alcohol.
- Heavy alcohol use. It causes cirrhosis. Liver cancer can also occur in heavy drinkers who do not have cirrhosis.
Liver cancer is the sixth leading cause of cancer death in the United States.
When to get checked
There is no standard or routine screening test for liver cancer in the general population. NCI names three tests that are used or studied for screening in people at higher risk: ultrasound, CT scanning, and the alpha-fetoprotein tumor marker.
AFP is the most widely used marker for finding liver cancer. NCI is candid about its limits. Other cancers, pregnancy, hepatitis, and cirrhosis can all raise AFP. And the level can be normal even when liver cancer is present.
So this cancer is watched for in people already known to be at risk. If you have chronic hepatitis B, chronic hepatitis C, or cirrhosis from any cause, ask whether you are on a watch schedule, and how often.
Contact a clinician promptly for:
- Yellowing of the skin or the whites of the eyes.
- Swelling of the abdomen, or a hard lump under the ribs on the right.
- Pain in the upper right abdomen or the right shoulder blade.
- Unexplained weight loss, loss of appetite, or feeling full after eating very little.
- Nausea, vomiting, or unusual tiredness with known liver disease.
AFP, triple-phase CT, and staging
The workup begins with an exam and a history. Blood tests follow: an AFP level and liver function tests.
Imaging then defines the lesion. Triple-phase CT takes images at three points after dye is injected. Liver tumors change appearance as the dye washes in and out. MRI is also used.
Stage reflects tumor size and number. It also reflects spread into blood vessels, nearby organs, and distant sites. Liver function is weighed alongside stage. A tumor that could be removed may still be off limits if the liver is too damaged.
From surveillance to transplant
NCI lists a wide set, and which applies depends on both the tumor and the liver.
Surveillance is used for lesions under 1 centimeter found on screening, with follow-up often every 3 months.
Partial hepatectomy removes the part of the liver holding the cancer, plus a margin of healthy tissue. The rest of the liver takes over and may regrow.
Liver transplant removes the whole liver and replaces it with a donated one. It may be used when the disease is confined to the liver and a donor organ can be found.
Ablation therapy destroys tissue in place. Types include radiofrequency ablation, microwave therapy, and cryoablation. Injecting pure alcohol into the tumor is another.
Drug treatment, where sorafenib sits, comes in when the cancer is advanced. Our page on targeted therapy covers that class, and liver cancer covers the disease.
Why these numbers are so low
These SEER figures cover liver and intrahepatic bile duct cancer across the US population. They describe a group, not a person.
Five-year relative survival is 21.9 percent for cases from 2016 to 2022. By stage it is 37.4 percent while confined to the liver, 13.4 percent once it reaches nearby lymph nodes, and 3.6 percent once it has spread further. About 45 percent are found at that first stage. An estimated 42,340 new cases and 30,980 deaths are projected for 2026, and median age at diagnosis is 68.
Those numbers are heavy, and the reason is structural. Most people who develop this cancer already have a damaged liver. That limits what treatment the organ can survive.
What this approval cannot tell you
The 2007 change widened who could receive an existing drug. It did not change the drug. It did not make it a first choice either.
Sorafenib is one option among several for advanced liver cancer, and the field has moved since. Whether it fits one person depends on liver function, other conditions, other medicines, and the goals of treatment.
Sources
- FDA, NEXAVAR (sorafenib) prescribing information, hepatocellular carcinoma indication added 11/2007 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021923s007lbl.pdf
- DailyMed, NEXAVAR (sorafenib) label, Initial U.S. Approval 2005 — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b50667e4-5ebc-4968-a646-d605058dbef0
- NCI, Sorafenib Tosylate — https://www.cancer.gov/about-cancer/treatment/drugs/sorafenibtosylate
- NCI, Liver Cancer Causes, Risk Factors, and Prevention — https://www.cancer.gov/types/liver/what-is-liver-cancer/causes-risk-factors
- NCI, Liver Cancer Screening — https://www.cancer.gov/types/liver/what-is-liver-cancer/screening
- NCI, Liver Cancer Diagnosis — https://www.cancer.gov/types/liver/what-is-liver-cancer/diagnosis
- NCI, Liver Cancer Treatment — https://www.cancer.gov/types/liver/patient/adult-liver-treatment-pdq
- SEER Cancer Stat Facts, Liver and Intrahepatic Bile Duct Cancer — https://seer.cancer.gov/statfacts/html/livibd.html
How this article was prepared
An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.
The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.
See an error, old source, or unclear wording? Tell us.
Know someone who needs this?
Plenty of people are looking for something like this and do not know where to start. If this would help a friend or someone you love, send it on — we have written an opening line so you do not have to stare at an empty message. You can change every word of it.
Your message is written and sent in your own email or messaging app — we never see who you send it to, and nothing is added to any list.
Put the story in context
Prevention, possible warning signs, screening, and diagnosis
This story relates to Liver cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.
Prevention and risk reduction
Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.