Lack of FDA Guidance on KRAS Testing Creates Confusion; Pharmas See Lower Sales | GenomeWeb

The lack of clear guidance from the US Food and Drug Administration regarding KRAS testing to target treatment with anti-EGFR monoclonal antibodies for colorectal cancer is affecting sales of such drugs and putting drugmakers in a difficult spot with regard to what they can and cannot say to doctors.

During an earnings call Last week, BMS said confusion over KRAS testing caused fourth-quarter US sales of its colorectal cancer drug Erbitux to slide 2 percent to $179 million from the year-ago period.

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