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Cancer blog: Fda Approves Erbitux For Head And Neck Cancer

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March 2, 2006

Fda Approves Erbitux For Head And Neck Cancer

Fda Approves Erbitux For Head And Neck Cancer
U.S. Food and Drug Administration granted approval to cetuximab (Erbitux) for the treatment of head and neck cancer. The drug is now approved for use in head and neck cancer in combination with radiation therapy (RT) for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. The drug may also be used as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.

Erbitux is already approved by FDA for the treatment of metastatic colorectal cancer. This new approval for the treatment of head and neck cancer is based on a study which showed statistically significant improvement in overall survival and duration of locoregional disease control for the combination of radiation therapy with cetuximab when compared to radiation therapy alone. In a separate clinical trial cetuximab was found to be effective with durable objective tumor responses when administered as a single-agent in second- or third-line treatment of advanced SCCHN.

The FDA approval is mainly based on a phase 3 randomized trial of 424 patients with Stage III/IV SCC of the oropharynx, hypopharynx or larynx who had no prior therapy. Patients were randomized to receive either cetuximab plus RT (211 patients) or RT alone (213 patients). Cetuximab was administered as a 400 mg/m² initial dose, followed by 250 mg/m² weekly for the duration of RT(6-7 weeks), starting one week before RT. RT was administered for 6-7 weeks as once daily, twice daily or concomitant boost.

The median survival time was 49 months on the cetuximab plus RT versus 29.3 months observed in patients receiving RT alone. The median duration of locoregional control was 24.4 months in patients receiving cetuximab plus RT versus 14.9 months for those receiving RT alone. The observed effect was primarily confined to patients enrolled in sites in the US.


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Cancer is a very common disease, approximately one out of every two American men and one out of every three American women will have some type of cancer at some point during the course of their life. Cancer is more common in the elderly and 77 percent of cancers occur in people above age 55 or older. Cancer is also common in children. Cancer incidence is said to have two peaks once during early childhood and then during late years in life. No age period is completely exempted from development of cancers. Some cancers occur predominantly in the elderly, other types occur in children, Cancer occurs in all ethnic races, however the cancer rates and rates of specific cancer types may vary from group to group. Late stages of cancer may be incurable in most cases, but with the advancement of medicine, more and more cancers are becoming curable.

Cancer blog: Fda Approves Erbitux For Head And Neck Cancer

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