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FDA Wants New First-Line Trial Data for Erbitux

Tue, 03/03/2009 - 5:36am
NEW YORK (AP) — Bristol-Myers Squibb Co. and Eli Lilly and Co. said Monday the Food and Drug Administration delayed a new marketing approval for their cancer drug Erbitux, asking for additional study data. The companies are seeking approval to market Erbitux as a first-line, or primary, treatment for squamous cell carcinoma of the head and neck. But they said the FDA wants a new pharmacokinetic study, or one that evaluates how the body processes the drug. The FDA wants to confirm that clinical studies of Erbitux match the way it is marketed. Erbitux is currently approved as a treatment for locally advanced squamous cell carcinomas of the head and neck in patients who are undergoing radiation therapy, or for patients whose disease has returned or progressed after chemotherapy. It is also approved to treat colorectal cancer. The two companies market Erbitux through a partnership. Eli Lilly gained a stake in the arrangement after buying ImClone Systems Inc. in November. Last month, the companies decided to withdraw an application asking to market Erbitux for advanced non-small cell lung cancer.
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