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The regulatory agency cited concerns over the benefit of using Avastin for treating breast cancer, adding that side effects of the drug include severe bleeding and heart failure and there is no proof that it helps treat that type of cancer.
Although Avastin is not considered a safe and effective drug for treating breast cancer, the drug will remain on the market to treat different types of brain, colon, kidney and lung cancer.
Avastin recorded sales of 6.5 billion Swiss francs ($7.1 billion) in 2010, according to Dow Jones Newswires.
“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that drugs they take are both safe and effective for their intended use," FDA commissioner Margaret Hamburg said in a statement.
Roche shares declined 0.35% to 142.80 Swiss francs in late afternoon trading in Zurich. In the U.S. market, shares of Roche climbed 1.06% to $39 per share in late morning trading.