Impending FDA Avastin Decision Ignites Controversy

<"">Avastin, the best selling cancer drug in the world, may no longer be a last-ditch option for breast cancer patients if the US Food & Drug Administration (FDA) follows a recommendation from one of its advisory panels. Last month, the panel voted 12-1 to recommend that approval of Avastin to treat breast cancer be rescinded. The vote was based on two new studies that the advisers concluded had not shown that the drug extends life.

The FDA is not required to follow the recommendations of advisory panels, but it usually does so. However, when it initially approved Avastin as a treatment for breast cancer, it did so against the recommendation of an advisory panel.

Avastin was first approved by the FDA in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. In 2008, the FDA also approved Avastin as a metastatic breast cancer treatment in combination with a chemotherapy drug called paclitaxel, and in May 2009, it was approved to treat glioblastoma multiforme, an incurable brain cancer.

Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. Its breast cancer indication was granted under an accelerated process that is based on initial positive studies. Companies then have to submit additional data to gain full approval. Avastin’s breast cancer approval was based on an initial trial that showed it lengthened the time until the disease worsened, though it did not prolong the women’s lives by a statistically significant amount.

Since then, two new studies failed to show the same ability to delay disease progression. They also indicated that women being treated with Avastin were more likely to suffer from a variety of potentially serious side effects, including blood clots, bleeding and heart failure

If the FDA does revoke Avastin’s breast cancer approval, it would remain on the market, as it is approved for other cancers. And doctors would still be legally able to prescribe it “off label” to breast cancer patients – at least to those who could afford it.

According to an article in The Washington Post, Avastin costs around $8,000 a month. If the FDA does rescind its breast cancer approval, insurers – including Medicare – would likely stop paying for it for this purpose. Breast cancer patients would also lose eligibility for a program in which Genentech, the maker of Avastin, caps the annual cost of the drug at $57,000 for women with annual incomes of less than $100,000.

For its part, the FDA is not supposed to consider cost in making decisions on treatments. But some experts advocating for revocation of Avastin’s breast cancer indication do make mention of the price tag.

“Patients with late-stage cancer are often desperate for help and grasp at straws,” Richard A. Deyo of the Oregon Health and Science University, told the Post. “Without this regulatory move, the drug would continue to be used, and would presumably not benefit anyone and add a lot of treatment costs.”

Many patient advocates who favor giving patients as much access to as many treatments as possible find this alarming. Some patients have even started petition drives to persuade the FDA to ignore the panel’s recommendation, the Post said.

“This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit,” Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston., and chief scientific officer for Susan G. Komen for the Cure, told the Washington Post.

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