FDA APPROVES GENETIC TEST TO HELP SOME COLON CANCER PATIENTS, PHYSICIANS CONSIDERING ERBITUX THERAPY

The U.S. Food and Drug Administration have approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation.

The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has spread to other parts of their body (metastasized). Studies have found that Eribitux is not effective in those who have the mutation.

Erbitux targets the epidermal growth factor receptor (EGFR) on the surface of CRC cells. When certain chemicals in the body bind to EGFR, the receptor starts a complex chain of biochemical reactions inside the cell that signals the cancer cell to reproduce. Erbitux blocks EGFR, interrupting a signal to reproduce which can stop the growth of CRC cells. However, when CRC cells have a mutation in the KRAS gene, they continue to reproduce even when Erbitux blocks EGFR.

The therascreen KRAS RGQ PCR Kit was developed by QIAGEN Manchester Ltd., of Manchester, England.

Erbitux is co-marketed by New York City-based Bristol-Myers Squibb and Eli Lilly and Company of Indianapolis.