FDA panel: risks of Roche drug for breast cancer patients outweigh benefits in key study

By AP
Tuesday, July 20, 2010

FDA panel: Study did not show benefit with Avastin

WASHINGTON — Federal health advisers said unanimously Tuesday that a follow-up study of the Roche drug Avastin failed to show meaningful benefits for breast cancer patients.

A Food and Drug Administration panel of experts voted 13-0 that the risks and side effects of Avastin outweighed its benefits when used alongside the chemotherapy drug docetaxel.

The FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it lengthened the amount of time until the disease worsened by more than five months. As a condition of approval, Roche was required to conduct follow-up studies to further 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. Patients taking Avastin did not show a significant improvement in life span, the gold standard of cancer treatment effectiveness.

Additionally, patients taking Avastin reported significant side effects, including high blood pressure, fatigue and abnormal levels of white blood cells.

Roche scientists argued that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms slow — 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.

The FDA panel of cancer experts is reviewing the results of the two Roche studies and voting on whether they show a clear benefit for patients. The FDA is not required to follow the advice of its panelists, though it often does.

Later this afternoon the panel will vote on whether Avastin’s approval in breast cancer should be withdrawn. Avastin is also approved for colon, lung, kidney and brain cancer.

Avastin was Roche’s top-selling cancer treatment last year with global sales of $5.9 billion.

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.

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