The Food and Drug Administration have declined to approve use of Erbitux as a first-line treatment for head and neck cancer asking for additional study data.

 

Erbitux is marketed in the US by Indianapolis-based Eli Lilly and New York-based Bristol Myers-Squibb Co., and overseas by Germany’s Merck KGaA.

 

Erbitux, also known as cetaximub, is designed to block a protein called epidermal growth factor that is believed to play a role in cancer cell growth. The drug was already approved to treat colon cancer in 2004 as well as head and neck tumors in April 2004.

 

Bristol and Eli Lilly had asked the FDA to approve the market of Erbitux as a first-line, or primary treatment for squamous cell carcinoma of the head and neck based on favorable head and neck cancer data from overseas studies conducted by German drugmaker Merck KGaA.

 

But “the FDA requested an additional pharmacokinetic study to confirm the comparability of Erbitux used in the first-line head and neck submission as compared to Erbitux currently marketed in the United States.”

 

Bristol and Eli Lilly last month withdrew a separate application for Erbitux use for nonsmall-cell lung cancer after the FDA raised similar concerns.

 

The companies are hoping to get the drug approved as a first-line treatment of squamous cell carcinoma of the head and neck, a hard-to-treat cancer the American Cancer Society says will kill 13,100 Americans this year.