The food and Drug Administration announced today (16 december) that it recommends that Avastin (bevacizumab) cannot be used for the treatment of breast cancer.
The FDA said the drug benefits are offset by the health risks. The drug received accelerated approval from the FDA in 2008 for use in the treatment of breast cancer in conjunction with chemotherapy. However, four studies found that the survival of patients with advanced breast cancer patients are not increasing, nor has slowing the spread of the cancer, according to the Agency.
The four clinical trials, that the effectiveness and safety of a substance test before a drug can be approved, finds a link between the drug and severe high blood pressure, bleeding and hemorrhage and the development of holes in the lining that separates the left and right nose holes, as well as the perforations in the stomach and intestines, the FDA said. The drug is also linked to heart attacks and heart failure.
"After careful evaluation of the clinical data, we recommend that the breast cancer entry for Avastin are removed on the basis of evidence from four independent studies," Dr. Janet Woodcock, Director of the FDA Center for drug evaluation and research, said in a statement.
In July of this year, an independent Advisory Committee voted to revoke the approval of Avastin as a treatment for breast cancer after reading data from previous studies.
Woodcock said that none of the studies patients demonstrated that Avastin took longer lived or experienced a significant increase in serious side effects. But the limited effects of the drug, combined with the potential risks, led the FDA to the decision to withdraw the approval of the drug for the treatment of breast cancer, she said.
"The results of these studies are disappointing," Woodcock said. "We encourage the company to further research to determine where there may be certain groups of patients of this drug benefit can."
The FDA announcement does not mean, however, it will be removed from the market or have no effect on its use for the treatment of breast cancer. The announcement also has no effect on the drug used for the treatment of the colon, kidney, lung and brain cancer, according to the FDA.
Doctors who their patients treated with Avastin for breast cancer should use their own judgement or their patients using the drug should remain, the FDA said.
The FDA has notified the manufacturer, Genentech Avastin, of his recommendation to withdraw approval on the market of the drug for breast cancer treatment purposes. Genentech has the ability to request a hearing to contest the recommendation; If not, the hearing in 15 days, starts the FDA the process for the breast cancer indication of the drug.
Breast cancer patient advocacy group Susan g. Komen for the cure and the Ovarian Cancer National Alliance in August a statement urging the FDA to withdraw its recommendation of Avastin for the treatment of cancer of the breast.
She said that although the FDA approval is not necessary for a doctor legal to write a patient, Avastin has meant that insurance companies are unable to cover the drug can choose.
Pass: the FDA has begun the process of withdrawal of the approval of Avastin (bevacizumab) are used for the treatment of breast cancer.
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