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Cancer Drug Avastin Linked to Death Risk

Study Shows Risk of Dying Higher With Avastin Than Chemo Alone; Drugmaker Criticizes Study’s Methods

Genentech Responds continued...

“Overall, the authors note that ‘the absolute risk of treatment-related mortality is low’ and the data should be considered in the context of potential benefit with Avastin,” according to the statement.

“Like other cancer medicines, Avastin has serious risks that are clearly described in its label and need to be considered by doctors and patients, in the context of its potential benefits.

As we continue to study Avastin, our goal is to identify the people who will derive a more substantial benefit from the medicine. This is why the majority of our clinical studies include collection of blood, tumor tissue and DNA for biomarker analysis as part of a comprehensive biomarker program. 

To date, we have studied a large number of different biomarkers (more than 10,000 in animal models, and more than 100 in clinical studies) across many different types of cancer and we are dedicated to continuing this work.”

Questions About Avastin

Avastin is a monoclonal antibody that works by blocking the formation of new blood vessels, which helps to choke off a tumor’s supply of oxygen and other nutrients.

It was first approved in 2004 in the U.S. for treatment of colorectal cancers.

Avastin has subsequently been approved to treat non-small-cell lung cancer, glioblastoma, renal cell carcinoma, and metastatic breast cancer.

Just months after it went on the market, however, the FDA warned doctors that the use of the drug appeared to be associated with a twofold increased risk of thromboembolic events, including heart attacks and strokes.

Other warnings were issued by the agency in 2006 and 2007 about increased risks for a rare brain capillary leak syndrome and non-gastrointestinal fistulas in patients on Avastin.

And in December 2010, the agency moved to rescind the drug’s breast cancer indication, saying Avastin had not been proven to be safe or effective for that use.

If the indication is removed, doctors could still use the drug in an off-label way to treat breast cancer, though it is far less likely that it would be covered by insurance. “Off-label” refers to the legal practice of prescribing medication for a purpose not approved by the FDA.

According to an editorial that accompanies the study, the drug costs more than $50,000 a year.

Genentech is appealing the agency’s decision, saying that patients deserve to have the treatment option.

“Avastin has helped people with five different incurable cancers; many have lived a longer time without their disease worsening, and in certain cases, Avastin has extended their lives,” says Charlotte Arnold, senior manager of corporate relations for Genentech.

According to IMS health, a company that tracks pharmaceutical sales trends, from October 2009 through September 2010, global sales of Avastin were around $5.5 billion, making it the world’s top-selling cancer medication.

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