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Roche cancer drug could lose FDA approval

Follow-up studies of a Roche breast cancer drug have shown that it failed to slow tumour growth or help patients live longer.

This content was published on July 16, 2010 - 20:25

This could lead to the drug Avastin being taken off of the American market, as US government health scientists announced on Friday.

The Food and Drug Administration (FDA) approved Avastin in 2008, basing its decision on early-stage trials.

However, follow-up studies done by Swiss pharmaceutical giant Roche indicate that the drug does not significantly extend lives when compared with chemotherapy alone.

According to the FDA, more recent data showed that patients experienced more side effects like high blood pressure and fatigue.

On Tuesday the FDA will ask a panel of cancer experts to review the study results.

The FDA may ultimately decide to withraw its approval for Avastin, which was Roche's top-selling cancer drug in 2009 -- with global sales of $5.9 million (SFr6.2 million).

swissinfo.ch and agencies

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