FDA Approved Drugs

The following drug has been approved since the year 2000 for the treatment of liver cancer:

Nexavar (sorafenib)

FDA approved November 2007

This drug is approved for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.

In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug.

According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months.

Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.

The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.