Erbitux has been approved since 2004 to treat colorectal cancer for late stage cancer after chemotherapy treatments had ended. The drug sends a signal to stop the growth of tumors in short. When a KRAS gene mutation is found, the tumors continue to grow so with finding this mutation it gives additional information on whether or not the patient should be on the medication or whether the treatment would not do any good.
The FDA also approved the use of the drug in combination with Folfiri chemotherapy drugs as a first line treatment for patients with metastic tumors with CRC . BD
The U.S. Food and Drug Administration today 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.
CRC is the third leading cause of cancer death in the United States. According to the American Cancer Society, there were more than 141,000 new CRC cases in 2011, and nearly 50,000 deaths resulted from CRC.
Among patients with tumors that did not have one of the seven KRAS mutations, median survival was 23.5 months for those who received Erbitux plus FOLFIRI compared with 19.5 months for those who received FOLFIRI. Among patients whose tumors had a KRAS mutation, median survival was similar between those who received Erbitux compared with those who did not.