US drug regulator FDA has revoked approval of breast cancer drug Avastin because of its damaging side effects. It is also declared that there is no evidence that the drug extends the life as well as quality of life of advanced breast cancer patients.
The blockbuster drug Avastin is used to treat breast cancer that has spread to other parts of the body. The drug functions by starving cancer cells from a blood supply. However, side effects of the drug may include severe blood pressure, heart attack or heart failure, substantial bleeding and perforations in stomach and intestine.
Avastin is the best-selling cancer drug in the world and it also is used to treat certain forms of colon, lung, kidney and brain cancers. The FDA allowed Avastin in 2008, to be promoted as a treatment for breast cancer that has spread, or metastasized, to other parts of the body and which is generally measured incurable.
The approval by FDA on the drug had preliminary been given under a special program, which allows patients to begin using promising treatments while the drug manufacturer finishes the studies to prove the medicine works in addition to expected. Some insurance companies already had quit covering the drug’s used in breast cancer after FDA’s advice.
According Margaret Hamburg, FDA’s commissioner, with so much at wager, patients and their doctors rely on the FDA to ensure the drugs they use have been shown to be safe and effective for their future use. Sometimes, the results of rigorous testing can be disappointing. Some supporters of the drug differ with the decision of watchdog.
The end product is that they are throwing out the baby with the bathwater. There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin, explained Dr Elisa Port, co-director of the Dubin Breast Center from Mount Sinai Hospital in New York.
The Swiss manufacturer of the drug Roche stated that it will carry out further study of the treatment, especially with the chemotherapy drug paclitaxel. They try to identify which patients might be best suited to benefit from use of the drug. The data showed only a small effect on patients’ tumor growth.
Genentech, part of Swiss drug manufacturer Roche Group, had argued that Avastin should remain available while it conducts more research to see if certain groups of patients might benefit from the drug, not that they were living longer or had a better quality of life and not enough benefit to outweigh such severe side effects, FDA concluded.