Avastin Not so Helpful
Posted 12/27/2010
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Some of you likely have been following the news about the FDA's decision to withdraw approval of Avastin in the treatment of breast cancer. Based on an early positive study in 2008, it had been given accelerated approval with the caveat that it would be examined later after more data was available. This second look happened recently, and the news was much less good. The data indicated that Avastin failed to extend lives for women with metastatic breast cancer and sometimes caused devastating, possibly fatal, side effects.
This decision has been received positively, although sadly, by most people, including some breast cancer advocacy groups. I, too, feel that care must be based on scientific evidence; the phrase is "evidence-based care", and that is the hallmark of quality cancer treatment. Of course, there are some women receiving this drug who feel that it has been helping them--and maybe it has been. We all know that statistics are based on large groups of people, and there are always outliers at both ends of the curve. This must be very distressing news for them. Although their doctors can continue to prescribe Avastin "off label" (meaning for a non approved purpose), it is likely that insurance companies will refuse payment. A year's course of Avastin can cost $88,000 and not too many families can afford that bill.
This is all an introduction to an excellent article from the New York Times:
Avastin
The Food and Drug Administration is preparing to withdraw its approval for using Avastin, a tumor-slowing drug, to treat advanced breast cancers that have spread to other parts of the body. It was a reasonable decision, based on scientific evidence. The drug has failed to extend lives in clinical trials, and it carries a small risk of devastating, sometimes fatal, side effects.
The agency's move has brought protests from some patients who think Avastin is helping them and charges from conservative critics that this is a step toward rationing. If the F.D.A. does rescind its approval, insurers may stop covering the drug for breast cancer. Few patients can afford to pay the exorbitant costs — as high as $88,000 a year — out of pocket.
We believe the F.D.A. has shown courage in following the scientific evidence on this highly emotional issue. Even some advocacy groups for breast cancer patients have applauded the agency's decision for making clear that the drug does not work very well.
Women whose breast cancer has spread have few good options. Their advanced disease is essentially incurable, so the best they can hope for is a treatment that will extend their lives or improve their quality of life.
Two years ago the F.D.A., bending over backward to be compassionate, gave Avastin "accelerated approval" for breast cancer treatment based on a single, unimpressive clinical trial. The results showed that Avastin, when added to standard chemotherapy, slowed the progression of the tumors for 5.5 months for the median user but did not extend lives. Two follow-up trials submitted by the manufacturer, Genentech, found tumor progression was held at bay for even shorter periods, from one to three months, and again, lives were not extended.
Worse yet, some patients suffered serious, disabling side effects, including severe bleeding, stroke or heart problems, severe high blood pressure and development of holes in the gastrointestinal tract. Roughly 1 percent of the patients died from Avastin-related causes.
Expert opinion is split on whether the extremely modest benefits of the drug are worth the risks. An advisory committee to the F.D.A. voted 12 to 1 in July that the approval for breast cancer should be withdrawn. The top British advisory group declined this month to recommend the drug for breast cancer because of its uncertain benefits and lack of proof it extended survival. However,the top advisory agency for the European Union ruled this month that the benefits outweighed the risks.
Genentech plans to request a hearing with the F.D.A. to argue the case for retaining Avastin's status as an approved breast cancer treatment. It should focus on proposing ways to identify the subset of women who can really benefit from Avastin.
For the full article:
http://tinyurl.com/2v4ep69
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