National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
November 15, 2011 • Volume 8 / Number 22

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FDA Update

Cetuximab Approved for Patients with Advanced Head and Neck Cancer

The Food and Drug Administration (FDA) last week approved the targeted drug cetuximab (Erbitux), in combination with chemotherapy, for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.

The approval was based on the results of an international phase III clinical trial of 442 patients with metastatic or recurrent squamous cell cancer of the head and neck who had not previously received chemotherapy. Patients treated with cetuximab and chemotherapy (5-FU in combination with either cisplatin or carboplatin) had improved overall survival compared with patients who received chemotherapy alone (10.1 months versus 7.4 months). Patients who received cetuximab had a higher incidence of several side effects, including diarrhea, respiratory and other infections, and serious infusion reactions.

Cetuximab, which targets the epidermal growth factor receptor, is already approved for patients with nonmetastatic head and neck cancer and for some patients with advanced colorectal cancer.

Also in the News: Federal Judge Blocks FDA Graphic Cigarette Warning Labels

On November 7, U.S. District Court Judge Richard J. Leon, in response to a lawsuit brought by five tobacco companies, issued a preliminary injunction staying the Food and Drug Administration (FDA) from implementing and enforcing its rule requiring larger, more prominent graphic health warnings on cigarette packaging and advertising until 15 months after a final ruling by the district court on the merits of the legal challenge to the rule. 

The FDA published a final rule in June 2011, requiring that, as of September 2012, cigarette packages and advertisements contain graphic health warnings that cover the top half of the front and back of packages, and 20 percent of the area of advertisements. The new warnings contain nine different warning statements, each accompanied by a different graphic image. A requirement of the 2009 Family Smoking Prevention and Tobacco Control Act, the new health warnings mark the first change in cigarette warnings in more than 25 years. They are aimed at effectively communicating to consumers the specific health risks caused by smoking, including death, addiction, lung cancer, stroke, and heart disease.

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