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Erbitux: FDA Priority Review, Expanded Use for ImClone´s Cancer Drug

ImClone System Inc’s Erbitux will receive a priority review by U.S. health regulators to expand its use with chemotherapy as a first-line treatment for patients with recurring head and neck tumors, reported the company.
10-31-2008 |  11:43 hs.
Author: Cate Kirby |

ImClone System and partner Bristol-Myers Squibb announced their jointly marketed head, neck and colon cancer drug Erbitux has been granted a priority review by the Food and Drug Administration (FDA) to expand its us with chemotherapy as a first-line treatment for recurring head and neck tumors.

The priority review designation – granted when there are no other adequate treatments available - means the FDA will review the application within six months rather than the usual 10-month period, the New York-based companies stated.

Erbitux, ImClone's only product and jointly sold with Bristol-Myers Squibb in the U.S., generated $840 million dollars in the first six months of this year. German drugmaker Merck KGaA sells the drug in Europe.

In October, Eli Lilly & Co announced it would be buying ImClone Systems for $ 70 a share, a deal valued at $ 6.5 billion dollars.

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