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US health advisers have said tests of a breast cancer drug have shown it had little positive impact on the patients involved in the study.
The risks and side effects involved in Avastin outweigh the benefits when used alongside chemotherapy drug docetaxel, according to the the US Food and Drug Administration (FDA).
The regulatory body approved the drug two years ago on the basis that results from a previous trial showed it lengthened the amount of time until the disease worsened.
But as a condition of the approval, pharmaceutical company Roche, which manufactures the drug, was told to carry out further tests.
The trials had to demonstrate the benefits of adding Avastin alongside 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 lifespan, 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 tumour growth and other symptoms slowed, but panellists were not convinced.
Natalie Compagni Portis, the panel’s patient representative, said: “The study shows there’s very little benefit to patients with significant toxicity risks and no clear survival benefit.”
The panel will vote on whether Avastin’s approval for use against breast cancer should be withdrawn in the US. Avastin is also approved for colon, lung, kidney and brain cancer.
Copyright Press Association 2010
