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US Panel: Study Showed No Benefit With Avastin

From Associated Press (July 20, 2010)

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 approved Avastin in 2008 for breast cancer patients based on a trial that showed it lengthened by more than five months the amount of time until the disease worsened. As a condition of approval, Roche was required to conduct follow-up studies to demonstrate further the benefits of adding Avastin to conventional chemotherapy.

Two follow-up studies recently submitted by the Swiss drug maker did not show the same degree of delay in cancer progression as earlier studies. Patients taking Avastin did not show 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 slowed, 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 whether they show a clear benefit for patients. The FDA is not required to follow the advice of its panelists, although it often does.

Later Tuesday,the panel was to vote on whether Avastin’s approval for use against breast cancer should be withdrawn.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 United States were attributed to the disease.


Posted: July 2010