Wednesday, December 24, 2008

Lilly, Amgen Says Gene Mutation Effects Should Be Listed on Cancer Drug Labels

It has been made public knowledge that drug makers Eli Lilly & Co. and Amgen Inc. told U.S. regulators on Tuesday that instructions on the cancer drugs Erbitux and Vectibix should include information on a gene mutation that affects whether the medicines will work.

The Bloomberg news reports that recent research showed that a mutation in the KRAS gene renders the drugs ineffective in colon cancer patients.

In addition, it is said the risk of a patient's colon cancer worsening was reduced by the drugs by about 30 percent.

Still, it should be noted that more detailed analyses showed that patients with KRAS mutations fared much worse than those with a normal KRAS gene, Bloomberg news reported.

Furthermore, according to the news service, an FDA advisory panel met Tuesday to discuss data on the KRAS gene mutation.

It is said that the advisers said new types of analyses may be required to better screen people for gene mutations, and they also suggested larger clinical trials may be necessary to determine other biochemical influences on drug performance.

The Bloomberg news service reports that Advisory panel member Derek Raghavan, director of the Taussig Cancer Institute at the Cleveland Clinic, said: "Two companies have come to us to try to create a situation where they sell less products. This is the first time I've seen this at the FDA."

To conclude, at this stage, it should be noted th at the FDA is currently working to identify genes that interact with medications.