NCI Cancer Bulletin: A Trusted Source for Cancer Research News
NCI Cancer Bulletin: A Trusted Source for Cancer Research News
December 4, 2007 • Volume 4 / Number 31 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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FDA Update

FDA Approves Liver Cancer Drug; Cautions on Smoking Cessation Agent

The U.S. Food and Drug Administration (FDA) recently approved sorafenib (Nexavar) for use in patients with inoperable hepatocellular carcinoma.

Sorafenib was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer. A kinase inhibitor, it interferes with molecules thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

In a separate action, FDA recently issued an Early Communication about its ongoing safety review of varenicline (Chantix), a drug approved as an aid to smoking cessation treatment.

After receiving a case report citing erratic behavior in an individual who had used varenicline, FDA has asked Pfizer, the manufacturer, for any information on additional cases of suicidal ideation in patients who have taken the drug. A safety analysis is under way. In the meantime, FDA recommends that health care providers monitor patients taking varenicline for behavior and mood changes.