FDA, ASCO, and NCCN issue statements supporting KRAS testing

Several organizations have recently issued statements supporting KRAS testing

·  The FDA has updated the "indication and usage" section of the labels of  with cetuximab (Erbitux®) or panitumumab (Vectibix®) to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13," and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.

·  The American Society of Clinical Oncology (ASCO) issued a Provisional Clinical Opinion on the use of KRAS gene mutation testing in patients with metastatic colorectal cancer to guide treatment with monoclonal antibodies against the epidermal growth factor receptor (EGFR) protein, such as cetuximab and panitumumab.  The ASCO document recommends that all patients with metastatic colorectal cancer who are candidates for anti-EGFR therapy have their tumors tested for KRAS gene mutations.  If a patient has a mutated KRAS gene, ASCO recommends against the use of anti-EGFR antibody therapies.  This recommendation is based on a series of recent studies indicating that anti-EGFR antibody therapies are effective only in patients with a normal (wild-type) version of the KRAS gene.  Studies have shown that 35% to 45% of colon cancer patients have KRAS mutations in their tumor specimens.  

·  The National Comprehensive Cancer Network (NCCN) also recently modified their treatment guidelines for colon cancer to include testing for KRAS mutations as a part of the clinical workup for patients with stage IV disease who are being considered for cetuximab or panitumumab therapy.  These recommendations represent prime examples of a personalized medicine approach in cancer therapy.

·  Managed care plans, including UnitedHealthcare, are now incorporating KRAS testing into their guidelines for colorectal cancer patients. 


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