FDA To Rule on Breast Cancer Drug

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Thursday, September 16, 2010 - 3:04pm

Decision could force patients to pay for medication out-of-pocket.

Some women in the advanced stages of breast cancer might soon lose one of the drugs in their arsenal against the disease.

Once put on the Food and Drug Administration's fast track, "Avastin" is now in jeopardy of losing its FDA approval to treat breast cancer in its advanced stages when tumors have spread to other parts of the body.

"Women receiving Avastin in randomized trials have actually done better than other drugs, but they have not lived longer and that's the major concern," says Dr. Stan Gerson of the UH Case Medical Center.

Avastin can come with side effects: Pain, blood clots, and a small risk for heart disease.

It also comes with a hefty price tag, $8,000 a month.

If the FDA does revoke the drug's approval for metastatic breast cancer insurers may no longer cover the cost for those women who do benefit.

Oncologists say it comes down to what's most cost effective for most patients.

"The biggest problem is that neither the drug company nor the community of oncologists has exactly figured out which women would benefit the most from Avastin," Dr. Gerson says. "For the thousands of women with breast cancer, perhaps we need to spend our money more developing better drugs that are more effective."

The looming FDA decision does not apply to Avastin's uses for colon and other cancers.

Final word on its use in breast cancer is expected sometime this month.
 

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