FDA Approves Nexavar for Patients with Inoperable Liver Cancer
The U.S. Food and Drug Administration today announced that it has
approved Nexavar (sorafenib) 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,” said Robert
Justice, M.D., director of FDA's division of drug oncology products. "This
is an important new treatment option for patients who are fighting this very
difficult form of cancer."
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. The
American Cancer Society estimates that there will be 19,160 new cases and
16,780 deaths from cancer of the liver and intrahepatic bile duct in the
United States in 2007.
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.
FDA's approval of Nexavar was based on the results of an international
randomized placebo-controlled trial in patients with inoperable
hepatocellular carcinoma. The study was designed to compare the survival of
a group of patients who received the drug against a group of similar
patients who did not.
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.
The most common adverse reactions that have been observed in patients taking
Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue,
weight loss, rash or superficial skin shedding, hand or foot skin reaction,
hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or
more of patients had experienced at least one of these reactions. In
patients with hepatocellular carcinoma, diarrhea was reported in 55 percent
of patients who received Nexavar. Inadequate blood supply to the heart or
heart attack were reported in 2.7 percent of patients who received Nexavar,
compared to 1.3 percent for patients who received placebo. New high blood
pressure was reported in 9 percent of patients who received Nexavar,
compared to 4 percent of patients who received placebo.
Elevated serum lipase, an enzyme that measures liver function, occurred in
40 percent of patients who received Nexavar, compared to 37 percent of
patients who received placebo, and hypophosphatemia, or low blood levels of
phosphate, occurred in 35 percent of patients who received Nexavar, compared
to 11 percent of patients who received placebo.
Nexavar comes in 200 milligram tablets and the usual dose is two tablets
(400 milligrams) taken twice a day on an empty stomach.
Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for
Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx
Pharmaceuticals, Inc., Emeryville, Calif.