Panel Recommends Against Avastin for Breast Cancer (American Cancer Society)

Panel Recommends Against Avastin for Breast Cancer (American Cancer Society)
An advisory panel for the US Food and Drug Administration(FDA) says the drug Avastin (bevacizumab) should not be approved for breastcancer treatment.
The Oncology Drug Advisory Committee recommended against FDA approval bya 5-4 vote Wednesday, noting that Avastin does not help breast cancerpatients live longer and can cause severe side effects. The FDA oftenfollows the recommendations of its advisory panels, but does not have to. Afinal decision by the agency is expected by late February 2008.
Avastin is approved to treat colon cancer and lung cancer.Studies have shown that Avastin helps patients with these cancers livelonger. Even if the FDA does not approve it for treatment of breast cancer,some doctors may still prescribe it "off label" for this use, althoughinsurance reimbursement might be an issue.
Survival Not Significantly Improved
In making its recommendation, the advisory panel reviewed the results ofa clinical trial involving 722 women with breast cancer that had returnedafter initial treatment or that had spread to other parts of their body.The women were randomly assigned to receive either Avastin plus thechemotherapy drug paclitaxel, or paclitaxel alone.
Adding Avastin to paclitaxel kept the cancer from growing for an averageof 11.3 months, compared to 5.8 months for the women getting paclitaxelalone. But overall survival was not significantly better, and women whoreceived Avastin had more serious side effects compared to those who gotpaclitaxel alone. Those included high blood pressure, blood clots, heartproblems, holes forming in the colon (bowel perforation) and high levels ofprotein in the urine, which is a sign of kidney damage. These are all knownside effects of Avastin.
In a report prepared for the panel, the FDA also said Avastin treatmentmay have caused as many as 6 deaths. However, Avastin's manufacturer,Genentech, disagreed with that assessment. The company's analysisattributed all those deaths to breast cancer or other causes, not totreatment with Avastin.
The advisory panel also reviewed the results of another clinical trialof Avastin in women who had previously been treated for metastatic breastcancer. In that study, the 462 patients received either Avastin incombination with the chemotherapy drug capecitabine, or capecitabine alone.Avastin did not significantly improve survival, or the time it took for thecancer to start growing again.
Genentech executives said they were "disappointed" by the committee'svote and will continue working with the FDA to get Avastin approved forbreast cancer.