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

Armen Hareyan's picture

Instructions on the cancer drugs Erbitux and Vectibix should include information on a gene mutation that affects whether the medicines will work, drug makers Eli Lilly & Co. and Amgen Inc. told U.S. regulators Tuesday.

Recent research showed that a mutation in the KRAS gene renders the drugs ineffective in colon cancer patients. Overall, the drugs reduced by 30 percent the risk of a patient's colon cancer worsening. However, more detailed analyses showed that patients with KRAS mutations fared much worse than those with a normal KRAS gene, Bloomberg news reported.


An FDA advisory panel met Tuesday to discuss data on the KRAS gene mutation. 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.

"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," said advisory panel member Derek Raghavan, director of the Taussig Cancer Institute at the Cleveland Clinic, Bloomberg reported.

The FDA is currently working to identify genes that interact with medications. The agency already requires patients to undergo genetic testing before they're prescribed certain drugs.


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