The US Food and Drug Administration (FDA) today approved cetuximab (Erbitux) in combination with platinum-based therapy plus 5-florouracil (5-FU) for use with chemotherapy to treat patients with late-stage head and neck cancer.

It follows successful clinical trials of European Union-approved cetuximab outside of the US on 442 patients with metastatic or recurrent head and neck cancer.

Erbitux, the US version, already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy or as a single agent.

Dr Richard Pazdur, director of the Office of Hematology and Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, explained that the ability of Erbitux to extend the lives of patients will be important for oncologists adopting a multi-treatment approach.

"Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible," he added.

Source:

FDA approves cetuximab with platinum-based therapy plus 5-FU for first-line treatment of SCCHN (08/11/11)

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