DEBATE FOR USE OF AVASTIN FOR BREAST CANCER WILL END AT 17 SEPTEMBER

August 20, 2010 — The use of bevacizumab (Avastin, Roche) in the treatment of breast cancer has hit the headlines again.

This week, many media outlets in the United State have been discussing the fact that US Food and Drug Administration (FDA) approval for the use of bevacizumab in the treatment of metastatic breast cancer could be revoked — although this news came out last month, as reported in detail at the time by Medscape Medical News.

On July 20, an FDA Oncologic Drugs Advisory Committee voted nearly unanimously in favor of removing this indication from the drug labeling. The FDA is now considering this advice; a decision is due on September 17.

The FDA usually follows the recommendations of its advisory committees, but not always.

In fact, when the FDA granted accelerated approval for bevacizumab for breast cancer in 2008, it went against the recommendation of its advisory committee, which was split on the issue (5 to 4).

At the time, bevacizumab had shown an improvement in progression-free survival but not overall survival. Accelerated approval was granted with a requirement for more data.

It was these additional data that were discussed at the most recent advisory committee meeting; they also showed an improvement in progression-free but not overall survival. The committee was not convinced of benefit, cited potential harm, and voted (12 to 1) for the approval to be rescinded.

Bevacizumab is approved for use in other cancers, so there is no threat of removal from the market. And even if the breast cancer indication is revoked, the drug would still be available for off-label use. However, that scenario would present problems with coverage by medical insurance companies.

Cost Is Big Part of the Debate

The cost of bevacizumab is a big issue, which has complicated the debate, as a report in the Washington Post illustrates.

"It's hard to talk about [bevacizumab] without talking about costs," Eric Winer, MD, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston, Massachusetts, told the newspaper. "For better or worse, [bevacizumab] has become in many ways the poster child of high-priced anticancer drugs."

It is the best-selling anticancer drug in the world, with annual sales of around $6 billion; nearly $1 billion of this comes from the breast cancer indication, according to analysts.

The Washington Post suggests that cost considerations are playing a part in the FDA deliberations, even though approval decisions should be based solely on safety and effectiveness. It reports that several members of Congress have sent protest letters to the FDA and the Department of Health and Human Services, including Sen. David Vitter (R-Louisiana), who wrote: "I fear this is the beginning of the slippery slope leading to more and more rationing under the government takeover of healthcare that is being forced on the American people."

Dr. Winer expressed concern about patients who would be denied the drug if the approval for breast cancer is revoked. "This is not a worthless drug by any means. There is almost certainly a group of women who get a great benefit," he told the newspaper.

However, other experts said that the cost of the drug should not be ignored.

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

Although the Washington Post presented different sides of the debate, the Wall Street Journal comes down heavily in favor of the drug in an editorial entitled The Avastin Mugging.

The piece — subtitled The FDA rigs the verdict against a good cancer drug — asserts that "the [bevacizumab] mugging is really an attempt to undermine regulatory modernization like accelerated approval . . . [and] is also meant to discourage innovations like [bevacizumab] that the political and medical left has decided are too costly, with damaging implications for the next generation of cancer drugs."

The looming FDA ruling "may deplete the drug arsenal for terminally ill cancer patients," it claims. "It would be a hideous injustice if the agency came down once more on the wrong side of a life-and-death question."