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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

    Questions About Avastin continued...

    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.

    Advice to Patients

    Patients diagnosed with the cancers Avastin is approved to treat are often told they have a limited amount of time to live, and in that context, a medication that can extend their life for a short time or even simply maintain their quality of life can be a precious glimmer of hope.

    Wu says he tries to carefully select the patients he puts on Avastin and he tries to help them understand that taking it is a gamble.

    “Normally, I explain to them the risk of this treatment, including the very bad risks that people may die from this treatment,” Wu says. “I also explain to them the potential benefits of treatment.”

    “If we watch them very carefully, it is a reasonably safe drug,” he says.

    When the cost is considered, however, the picture gets more complicated.

    “Available data suggest that [Avastin] is biologically active in most but not all solid tumors,” writes Daniel Hayes, MD, an oncologist who treats breast cancer at the University of Michigan Comprehensive Cancer Center, in his editorial on the study.

    “However, the benefits of extended adjuvant [Avastin] in unselected populations may not be justified by the modest disease-free survival and questionable overall survival benefits reported thus far.”

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