FDA OKs Avastin for Advanced Breast Cancer

By Amanda Gardner
HealthDay Reporter
Friday, February 22, 2008; 6:00 PM

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

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

"Avastin, in combination with paclitaxel [a chemotherapy drug], is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer," the agency said in a statement.

HER2-negative breast cancers account for about 60 percent of breast cancers. They can be slower-growing than HER2-positive cancers, but can still prove deadly.

"This is an important incremental advance for treatment for women with metastatic breast cancer," said Dr. Joseph Sparano, director of the breast evaluation center at New York City's Montefiore Einstein Cancer Center, who was also one of the investigators in the trial on which approval was based. "It remains an incurable disease, but it doesn't mean that it's not treatable."

However, the issue remains a controversial one. "Avastin improves progression-free survival, but we don't know if it improves overall survival," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "There are increased side effects [and] risks in using Avastin, but, in appropriate patients, it may be beneficial."

Side effects include, notably, an increased risk for blood clots and hypertension, as well as mild nose bleeds, Sparano said.

And the drug is expensive, Brooks noted. According to The New York Times, treatment with Avastin for colon cancer currently costs about $50,000 per year.

In a statement issued Friday afternoon, Genentech said Avastin won accelerated approval "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."