Testing of Roche cancer drug extended

US authorities have extended testing time for the Roche breast cancer drug Avastin. The benefit of advanced breast cancer is not great enough to counter the side effects.

(20/09/2010) Pharmaceutical company "Roche" must continue to be patient until Avastin receives approval for breast cancer therapy in the United States. US authorities first want to review the benefits against the significant risks of advanced breast cancer. The drug is now with approximately 6.2 billion francs the sales-strongest drug of Roche. The drug is used in many other cancers.

Now the US Food and Drug Administration is taking more time to decide on approval of the drug Avastin from the pharmaceutical company Roche. The drug will be used to treat breast cancer. However, it is also used for cancer of the bowel, lung, brain and kidney for cancer therapy. As the company announced, the test phase was extended by three months. The decision will now be made on 17 December 2010. The FDA's Advisory Committee decided in July this year not to allow drugs in the drug market. The rationale for this step was that the benefits of Avastin in advanced breast cancer are not high enough. The considerable risks are unjustifiable for the patients. On July 20, 2010, external FDA reviewers recommended in 12 vs. 1 vote to revoke the approval for breast cancer: two studies have shown no significant prolongation in significant toxicity. In 2008, the US agency initially approved the breast cancer product for the time being. The American subsidiary "Gentech" stated that it now wants to provide the FDA with further information on the treatment of breast cancer patients in conjunction with chemotherapy.

The drug Avastin is now, with sales of about 6.2 billion francs a year, the sales-strongest drug of the Swiss group. The drug is also used in Germany for cancer immunotherapy. Other studies are currently underway to investigate efficacy in other cancerous tumors. Among other things, it involves cancers such as pancreatic cancer, gastric cancer, and prostate cancer. According to analysts, the cancer drug accounts for about 13 percent of the annual sales of the Roche Group.

A variety of drugs are flooding the drug market. Critics complain that many drugs have significant side effects. Recently, a drug with the drug "Rosiglitazone" was under heavy criticism. (Sb)

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Picture credits: Rainer Sturm