ImClone Systems And Bristol-Myers Squibb Announce Revisions To ERBITUX(R) (cetuximab) U.S. Product Labeling For Metastatic Colorectal Cancer
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for ERBITUX® (cetuximab) concerning the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The labeling revisions include a modification to the indication, which now includes a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Revisions concerning the use of ERBITUX in colorectal cancer tumors with K-ras mutations were also made to the clinical studies and clinical pharmacology sections of the product"s prescribing information.
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