FDA OKs Avastin for Advanced Breast Cancer

FRIDAY Feb. 22, 2008 -- 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."

An expert panel of advisers to the FDA voted 5-4 last December not to recommend approval because the drug's ability to slow 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 Associated Press. "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," advisory panel chairwoman Maha Hussain, an oncologist at the University of Michigan, 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 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 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 the $2.3 billion in sales that was generated in 2007 by the drug's use among lung and colon cancer patients.

Posted: February 2008


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