FDA panel reconsiders Roche’s breast cancer drug

WASHINGTON — Federal health advisers will vote Tuesday on whether to withdraw regulatory approval of the Roche drug Avastin for breast cancer treatment after the drug showed disappointing results in recent studies.

The Food and Drug Administration in 2008 approved Avastin for breast cancer patients based on a trial showing it significantly lengthened the amount of time until the disease worsened. As a condition of approval, Roche was required to conduct follow-up studies to further demonstrate the benefits of adding Avastin to conventional chemotherapy.

The FDA is asking a panel of experts to review two new Avastin studies in which the drug failed to show a survival benefit. Additionally, the follow-up studies did not show the same degree of delay in cancer progression as earlier studies.

The panel of cancer experts will vote on whether to withdraw Avastin’s approval in breast cancer. Avastin is also approved for colon, lung, kidney and brain cancer.

Panelists will be asked to weigh the potential benefits of the drug against its side effects, which include high blood pressure, fatigue and abnormal white blood cell levels.

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

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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