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So far Avastin, a drug used to slow the growth of colorectal and lung cancers, is have a tough time convincing regulators its use should be expanded to treat breast cancer.
Maker Genentech Inc. is trying though.
A second study is reported to show that Avastin slows the growth of breast-cancer tumors when combined with chemotherapy. This study was sponsored by Genentech's major shareholder, Roche Holding AG. and is a bid to expand its use, therefore expand profits.
February 23rd, the FDA will decide whether Avastin can be used for breast cancer patients, for whom it is already being used off-label. That approval could expand profits which totaled $2.3 billion in 2007.
But it has not been an easy climb. The drug is used to treat breast cancer that has spread or metastatic breast cancer. An earlier study of 722 women showed that Avastin combined with the drug Taxol appeared to stop cancer progression by 11.3 months. That is five months longer than Taxol alone.
But the drug combination did nothing to extend a woman's survival and there were side effects from Avastin such as hypertension, blood clots and bowel perforation as well as additional deaths.
Last December, an FDA panel voted against recommending Avastin for treating breast cancer.
Upon news of the latest positive trial results, shares rose in premarket trading Wednesday for Genentech 2.6 percent to $71.70 a share. However analysts say the drug has only a 40 to 50 percent chance of gaining FDA approval.
The FDA approved fewer drugs in 2007- 69 in all. That number represents a 26 percent drop from the previous year even as big pharmaceutical companies face a rash of patent expirations. Analysts say that facing criticism for being too easy on Big Pharma, the FDA is raising the bar on drug approvals. #