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Broader US label for Erbitux colorectal cancer drug

Tue Oct 2, 2007 11:36pm EDT

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NEW YORK, Oct 2 (Reuters) - ImClone Systems Inc IMCL.O and Bristol-Myers Squibb Co (BMY.N) said on Tuesday that U.S. regulators had approved a broadened label for their Erbitux drug to include survival data for its use as a single agent for advanced colorectal cancer patients who failed other drugs.

The approval of the Erbitux application was based on a late-stage clinical trial involving 572 patients.

"Erbitux is now the only approved biologic therapy to demonstrate improved overall survival as a single agent in patients with metastatic colorectal cancer," Martin Birkhofer, vice president of oncology global medical affairs at Bristol-Myers, said in a statement.



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