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FDA OKs Avastin for Advanced Breast Cancer
Date:2/22/2008

Drug has significant risks, experts say

FRIDAY, Feb. 22 (HealthDay News) -- The U.S. Food and Drug Administration went against the recommendation of its own advisory panel on Friday and approved the cancer drug Avastin for women with advanced breast cancer.

The agency cleared the drug, made by Genentech and already approved for treating lung and colon cancer, based on findings that it slowed tumor growth, the Associated Press reported.

In a prepared statement issued Friday afternoon, Genentech said 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. The approval is based on a Phase III study, called E2100, that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to those treated with paclitaxel alone and a doubling in progression-free survival."

"There is no cure for metastatic breast cancer, so it is important to control the disease as early and for as long as possible," Dr. Kathy Miller, lead investigator on the E2100 trial, said in the Genentech statement. "Now with Avastin plus paclitaxel, we can increase the time a womans cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone," added Miller, an associate professor of medical oncology at Indiana University School of Medicine.

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. In rare cases, patients taking Avastin with standard chemotherapy have died.

"Everybody wants to offer metastatic breast cancer patients hope, but we shouldn't offer them false hope," panel member Natalie Compagni-Portis, a patient representative with Breast Cancer Action in San Francisco, said during the December meeting, according to the AP. "We have to raise the bar in terms of safety."

"These patients are terminal, and it's our job to make their lives better, not to say that it's OK to have a stroke or that it's manageable," Maha Hussain, an oncologist at the University of Michigan and the advisory panel's chairwoman, said during the meeting. "You didn't show that patients are living better or that they're living longer."

In trial results submitted to the FDA by Genentech before the advisory panel met the use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with the chemotherapy drug paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.

However, the same study of 722 patients showed that patients reaped no gain in terms of their overall survival after taking Avastin.

Avastin is not traditional chemotherapy, but instead is a monoclonal antibody that robs tumors of their blood supply. 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.

According to Bloomberg News, Avastin is currently being tested against 20 cancers in 300 trials. This latest approval is expected to add more than $700 million in annual sales to Genentech's bottom line.

More information

Find out more about breast cancer and its treatment at the American Cancer Society.



SOURCES: Feb. 22, 2008, prepared statement, Genentech Inc., San Francisco; Associated Press; Dec. 5, 2007, FDA Briefing Document, Oncology Drug Advisory Committee Meeting


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