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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowIndianapolis-based Elli Lilly and Co. and New York-based partner Bristol-Myers Squibb Co. have failed to win U.S. approval to sell Erbitux as a first-line treatment for head and neck cancers.
Regulators questioned differences in American and European versions of the drug, which is already approved to treat colon tumors and certain drug-resistant head-and-neck malignancies.
The drugmakers received priority U.S. Food and Drug Administration review for an application in October to expand Erbitux use for head and neck tumors, a cancer that is difficult to treat.
A separate application for Erbitux in non-small cell lung cancer was withdrawn by the companies last month after the FDA raised similar concerns.
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