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Avastin gets unexpected FDA approval

Roche's majority owned biotech company, Genentech, defied critics and shareholders after the US Food and Drugs Administration approved its new breast cancer medication, Avastin, on February 22.

Roche's majority owned biotech company, Genentech, defied critics and shareholders after the US Food and Drugs Administration (FDA) approved its new breast cancer medication, Avastin, on February 22.

In December 2007 one of the FDA's advisory panels recommended that the FDA deny approval of the drug for breast cancer.

The committee voted 5-4 against expanding the approved use of Avastin to include breast cancer patients because the drug did not significantly lengthen the lives of women who took it alongside chemotherapy.

Initial indications showed that Avastin increased the risk of side effects such as heart attacks and its use was attributed to the deaths of six patients who were trail subjects.

Dr Kathy Miller, associate professor of oncology at Indiana University and lead investigator of Avastin clinical trails, said: "With Avastin plus paclitaxel, we can increase the time a woman's cancer is kept under control, and offer a biologic option to women who previously limited to chemotherapies alone."

HER-2 negative metastatic breast cancer, the type that Avastin will treat, killed close to 40,000 of the 170,000 women diagnosed with the disease in 2007.

The FDA gave accelerated approval to Avastin, which will be prescribed in conjunction with paclitaxel chemotherapy and has already shown a 52 percent reduction in the progression of breast cancer.

Dr Susan Desmond-Hellman, president of product development for Genentech, said: "This approval provides women who have not yet received chemotherapy for their metastatic breast cancer a new option to consider with their physician and families."

Women being prescribed the treatment will be eligible to support from the Avastin Patient Assistance Program that ensures a 12-month prescription period regardless of their insurance coverage.

Roche has rights to market Avastin outside the US.

25th February 2008

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