Colorectal Cancer News

KRAS Mutation Eliminates Vectibix and Erbitux for Stage IV Patients

Personalized cancer treatment took a giant step forward this month as the FDA OK'd a label change for Erbitux and Vectibix, narrowing the indication for advanced colon cancer. The label now recommends the drugs as a treatment for EGFR-expressing tumors only in patients without KRAS gene mutations. In this case, the drug makers, Amgen, Imclone/Eli Lilly and Bristol-Myers Squibb, asked for the restricted use and enlisted the help of the CCA to seek the label change. All companies now recommend that all patients should be tested for KRAS mutational status when considering treatment options for CRC patients. It is estimated that 40 percent of patients with advanced CRC have KRAS mutations.

What this means for patients is that a number of those with advanced disease will no longer have to be subjected to chemotherapies that we now know will not work on them. While drug manufacturers normally want their medicines to be used by as many patients as possible, this development is a clear signal that they are recognizing the value of tailoring medicines to specific individuals based on certain genetic or other biologic markers. The industry recognizes that even if the population for whom the drug works is smaller, it will be more effective for those patients; it is therefore more critical that those individuals take and be reimbursed for the treatment.

Amgen's Chief Medical Officer Sean Harper, in a July 17 statement, concluded that hysicians can eliminate Vectibix and Erbitux for colon cancer patients with the KRAS mutation and "redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit." This is really great news for the CRC community and a window into the future of cancer treatment.

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