Video: FDA: Avastin not approved to treat breast cancer

  1. Transcript of: FDA: Avastin not approved to treat breast cancer

    BRIAN WILLIAMS, anchor: A panel of federal cancer experts said today the cancer drug Avastin should no longer be recommended to treat breast cancer . The move comes after follow-up studies showed few benefits for breast cancer patients and no real increase in survival rates. The full FDA is now expected to follow the recommendation of this panel, which came, by the way, in a vote of 12-to-one.

updated 7/20/2010 7:20:54 PM ET 2010-07-20T23:20:54

A panel of cancer experts said Tuesday that the government should remove its endorsement of Roche's drug Avastin for breast cancer, after follow-up studies failed to show benefits for patients.

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

A Food and Drug Administration panel of experts voted 12-1 in favor of removing the drug's approval for use against breast cancer alongside chemotherapy.

The FDA is not required to follow the advice of its panel, though it often does.

The negative vote is the first major setback for a blockbuster cancer drug that has racked up approvals for half a dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling only pertains to Avastin's use in breast cancer.

The FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients' lives.

As a condition of approval, Roche was required to conduct follow-up studies to demonstrate the benefits of adding Avastin to conventional chemotherapy.

But two follow-up studies recently submitted by the Swiss drugmaker did not show the same degree of delay in cancer progression as earlier studies. Additionally, patients taking Avastin did not show a significant improvement in lifespan, the gold standard of cancer treatment effectiveness.

Roche scientists argued Tuesday that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms are delayed — but panelists were not convinced.

"The study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit," said Natalie Compagni Portis, the panel's patient representative.

Panelists said they worried the drug could do more harm than good because of serious side effects, including high blood pressure, fatigue and abnormal levels of white blood cells.

"I think the burden of proof is that a drug is helpful, not that it doesn't make patients worse," said panel chair Dr. Wyndham Wilson of the National Cancer Institute. "We have definitive evidence that Avastin causes harmful side effects and we've now seen a number of well-done studies that show no advantage to lifespan."

Breast cancer is the second most-common cause of cancer death among U.S. women, according to the Centers for Disease Control. Last year more than 40,000 deaths in the U.S. were attributed to the disease.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Discuss:

Discussion comments

,

Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments