US authorities have extended the trial period for Roche's breast cancer drug Avastin. The benefit of breast cancer in the advanced stage is not big enough compared to the side effects.
(09/20/2010) The pharmaceutical company "Roche" must continue to wait until the drug Avastin receives approval for breast cancer therapy in the United States. US authorities first want to review the benefits against the significant risks in the advanced stage of breast cancer. With around CHF 6.2 billion, the drug is now Roche's top-selling drug. The drug is now used in numerous other types of cancer.
Now the FDA is taking more time to decide whether to approve the drug Avastin from the pharmaceutical company Roche. The drug is said to be used to treat breast cancer. However, it is also used to treat cancer in colon, lung, brain and kidney cancer. As the company announced, the testing phase was extended by three months. The decision should now be made on December 17, 2010. The FDA's advisory committee had decided in July of this year that drugs should not be approved on the drug market. The rationale for this move was that Avastin's benefit in advanced breast cancer was not large enough. The considerable risks cannot be justified for the patients. On July 20, 2010, external FDA reviewers recommended by 12 votes to 1 vote to withdraw approval for breast cancer: two studies showed no significant prolongation of the test if the toxicity was significant. In 2008, the U.S. agency had provisionally approved the breast cancer drug. The American subsidiary "Genech" said that it would now like to provide the FDA with further information on the treatment of breast cancer patients in connection with chemotherapy.
The drug Avastin is now the Swiss pharmaceutical company's top-selling drug with sales of around CHF 6.2 billion a year. The drug is also used in Germany for cancer immunotherapy. Additional studies are ongoing to investigate the effectiveness of other cancer tumors. Among other things, it deals with forms of cancer such as pancreatic cancer, stomach cancer and prostate cancer. According to analysts, the cancer drug accounts for around 13 percent of Roche's annual sales.
A large number of drugs flood the drug market. Critics complain that numerous drugs have significant side effects. Recently, a drug with the active ingredient "rosiglitazone" was heavily criticized. (sb)
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