Avastin is already approved for treating lung and colon cancer, based on findings that it slowed tumor growth but does not help in patient survival. The ruling prompted a mixed reaction from both doctors and advocates for breast-cancer patients.
The drug is already prescribed "off-label" to an estimated 9,500 patients and for whom insurance coverage is limited. According to a press release by Genentech, the drug won accelerated approval "in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer."
Avastin, when combined with paclitaxel chemotherapy, resulted in a 52 percent reduction in breast cancer progression or death compared to those treated with paclitaxel alone.
Avastin was Genentech's best-selling product last year with revenue of $2.3 billion. Swiss drug maker Roche markets the drug in Europe through a partnership with Genentech. In Europe, the drug has already been approved as a breast-cancer treatment.
Last December, an expert panel of advisers to the FDA voted 5-4 that the drug's ability to slow down the growth of tumors did not outweigh the increased risk of blood clots and other cardiovascular troubles among users.
First approved in the U.S. to treat colon cancer in 2004, Avastin was the first drug to fight cancer by blocking nutrients from reaching tumors.
It has been found to boost the survival of patients with metastatic colorectal cancer and non-small-cell lung cancer when added to chemotherapy and used as a first-line treatment.
