FDA to decide fate of breast cancer drug Avastin

September 15, 2010 8:40:43 PM PDT
The Food and Drug administration will decide the fate of a popular cancer drug, in a matter of weeks. The debate is whether it should continue to be approved for treating breast cancer. Some believe that decision could be a glimpse at the future of health care policy in the United States.

Kaye Stevens has the scars to show from her battle against breast cancer and a table full of medications. But she credits one cancer-drug, Avastin, made by the Bay Area giant Genentech, with extending her life.

"I've been able to function have a relatively decent quality of life without tremendous side effects, and I've been tumor free," she said.

Berkeley oncologist Dr. Gary Cecche began giving Kaye Avastin as a stand-alone treatment nearly two years ago, after she showed severe side effects from other drug combinations.

"So for her it's not only improved her response, one would have to believe it's dramatically improved her survival," he said.

But recent studies reviewed by an FDA panel in July raised questions about Avastin's statistical effectiveness in treating breast cancer in a majority of women.

Tests combining Avastin with several other drugs found it delayed the progression of tumors by about a month to two and a half months on average.

The advisory committee voted 12-1 to remove Avastin's indication for treating breast cancer.

That recommendation has now touched off a fierce debate over the value of Avastin and perhaps other expensive cancer drugs in the future. On one hand, is the drug's effectiveness for a limited number of breast cancer patients, versus the high cost of prescribing it to thousands of others who may not see any long term benefit.

"The question is, is that this a valid drug to go on the market in terms of an economy where insurance companies are going to have to pay for it, and is this the right way to run a health care system in the united states," UCSF biopharmaceutical sciences professor Dr. Les Benet said.

Benet agrees with the advisory committee's vote, but also believes if the fda does remove avastin's approval for breast cancer, it could mark a turning point in the national debate over health care reform.

"It's the kind of problem we're going to face over and over again. It's not taking health care away from Grandma. Its saying as a society, are you willing to spend your money to pay for these kinds of treatments, when in fact it's not a cure," she said.

The average cost for Avastin is about $8,000 a month. But for Kaye, who's begun a letter writing campaign, the issue isn't just about money, or statistics, it's about individual patients rights.

"It should be an option between a patient and physician. How that drug might affect you is the absolute bottom line. Because I fee without it, I would not be here today," she said.

The FDA has indicated that it will make a decision by September 17.


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