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Home Industry News Bristol-Myers Squibb announces changes to Erbitux labelling

Bristol-Myers Squibb announces changes to Erbitux labelling

22nd July 2009

Bristol-Myers Squibb and ImClone Systems have announced that approval has been granted by the Food and Drug Administration for changes to the prescribing information for Erbitux (cetuximab) in certain regions.

The revisions include a change to the indication, which now states that retrospective subset analyses of metastatic or colorectal cancer studies have not shown a treatment benefit for the drug in people whose tumours had K-ras mutations in codon 13 or 12.

As such, the use of Erbitux is not recommended for the treatment of colorectal cancer with the aforementioned mutations.

Fouad Namouni, executive director of Erbitux in the department of oncology medical strategy for Bristol-Myers Squibb, said: “The inclusion of K-ras as a biomarker in the Erbitux labelling helps physicians to better understand the most appropriate use of the drug in the management of patients with metastatic colorectal cancer.”

The company is set to announce its financial results for the first six months of 2009 tomorrow (July 23rd).

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