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ImClone, Bristol-Myers Squibb file FDA application for expanded use of Erbitux


NEW YORK ImClone Systems and Bristol-Myers Squibb have submitted an application to the Food and Drug Administration seeking approval for an additional use of the drug Erbitux, the two companies announced Monday.

The drug makers hope to broaden the use of Erbitux (cetuximab) to include first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy (cisplatin/vinorelbine). The FDA will notify ImClone whether it has accepted the application for review in February.


“This submission reflects our continued efforts to maximize the potential of Erbitux by broadening its approved uses to include new indications such as non-small cell lung cancer, a disease for which there are few impactful treatments and for which less than one-in-five advanced-stage patients currently receive biologic-based combination therapy in the first-line setting,” ImClone executive vice president and chief medical officer Eric Rowinsky said in a statement.

The two companies collaborated to develop Erbitux, and Bristol owns a 16.6 percent share of ImClone. Indianapolis-based Eli Lilly and Co. recently acquired the New York-based biotech company, beating out a lower acquisition bid by Bristol.

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