Source: www.reuters.com
Author: Ransdell Pierson

U.S. regulators have declined to approve use of Erbitux as a first-line treatment for head and neck cancer until a new U.S. animal study is conducted showing how the medicine is absorbed by the body, drugmakers Eli Lilly and Bristol-Myers Squibb said on Monday.

Lilly and Bristol-Myers had asked the U.S. Food and Drug Administration to approve first-line use of Erbitux based on favorable head and neck cancer data from overseas studies conducted by German drugmaker Merck KGaA.

Merck sells Erbitux outside the United States. Lilly separately makes Erbitux and sells it in the United States in partnership with Bristol-Myers.

The FDA wants an additional study to ascertain that both batches of Erbitux have the same pharmacokinetic profile, meaning the drug is absorbed in the bloodstream in similar fashion and amounts, said Lilly spokeswoman Judy Kay Moore.

“They want an additional preclinical trial to study comparability” of Erbitux batches, Moore said.

Lilly and Bristol-Myers recently withdrew their U.S. application to market Erbitux for advanced non-small cell lung cancer because of the same need to confirm comparability of batches made in different plants.

“Essentially we will do one animal study and that will answer the pharmacokinetic comparability questions related to first-line treatment for both head and neck and lung cancer,” Moore said.

Lilly hopes to refile the lung cancer marketing application in the second half of 2009, Moore said.

She said the company does not need to refile its application for first-line treatment of head and neck cancer because it is a “standing application.” Moore declined to speculate when the FDA would receive the requested new data and render its decision on use of Erbitux for that condition.

Erbitux is already approved in the United States to treat advanced head and neck cancer, in combination with radiation, and as a stand-alone treatment for patients with recurrent or metastatic head and neck cancer that have failed to benefit from standard treatment. Its biggest use, however, is as a treatment for colorectal cancer.