Federal health authorities recommended Thursday that the blockbuster drug Avastin no longer be used to treat breast cancer, saying recent studies failed to show the drug's original promise to help slow the disease and extend patients' lives. The rare decision by the Food and Drug Administration is supported by many cancer experts but drew fierce opposition from cancer patients and some doctors who defend the drug and say it should remain available. The ruling is a significant setback for the world's best-selling cancer drug and will likely cost Swiss drugmaker Roche hundreds of millions of dollars in lost revenue. Avastin is also approved for various types of colon, lung, kidney and brain cancer. FDA officials stressed that the recommendation is only a preliminary step toward revoking the drug's approval for breast cancer. Roche has refused to voluntarily withdraw the indication, and the company said in a statement it would request a public meeting on the issue.
Avastin FDA Approval History
Reuters- U.S. panel rejects Roche's Avastin for breast cancer | Friends of Cancer Research
After more than a year of deliberations and an unprecedented public hearing in June, the agency has revoked approval of the biotech blockbuster Avastin, a medicine that chokes off the blood supply to various cancer cells, as a treatment for metastatic breast cancer. As a condition of approval, the company had to do more research on the drug. At a June hearing, the company and some breast cancer survivors made the case for preserving the approval. Many argued that the drug should keep its approval to preserve hope for women with aggressive breast cancer. Avastin remains on the market. Doctors are still free to prescribe Avastin for any use they see fit, including breast cancer. Advocates for the drug have worried a final decision by FDA against Avastin would cause more companies to follow suit.
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UPDATE 4-US FDA panel rejects Avastin for breast cancer use
The Food and Drug Administration said Thursday that it is beginning the process of revoking approval for the drug Avastin for use in the treatment of breast cancer. In a statement, the agency said that four independent trials have shown that Avastin does not increase life expectancy for breast cancer patients and that it has serious side effects, including high blood pressure, bleeding and hemorrhaging, holes in the intestines and stomach, and heart failure. But follow-up trials failed to find the same effect, or to show that the drug increased life expectancy.
The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials. The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.