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FDA pulls its approval of breast cancer medication Avastin

Knight Ridder/Tribune Business News

11-21-11

Nov. 19--Breast cancer survivor Chris Needles used the embattled cancer drug Avastin for 2 1/2 years.

She suffered some side effects, including randomly losing her voice for a few days, but by the time she stopped using it last year, the tumors were gone, she said. And they have not reappeared.

So Needles and others were disappointed with the Food and Drug Administration when it announced on Friday that it is revoking its approval of Avastin for breast cancer treatment. FDA Commissioner Margaret A. Hamburg said the drug has not been proved safe or effective, and it could cause life-threatening side effects.

"This was a difficult decision," Hamburg said in a statement. "FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use."

Needles, 47, of Mt. Lebanon has confidence in Avastin.

"I don't think they investigated how many people it did help," she said. "I don't think they took patients like me into consideration."

In her 69-page opinion, Hamburg wrote there is no evidence the drug prolongs life. Side effects include high blood pressure, bleeding and hemorrhaging, heart attack or heart failure, and the development of perforations in the nose, stomach and intestines.

Dr. Jane Raymond, director of medical oncology at Allegheny General Hospital in the North Side, said the FDA's decision was "unfortunate for many women with metastatic breast cancer."

"A number of studies show it prolongs response to chemotherapy, and others show it prolongs disease-free survival," she said. "I have found it to be a drug that we can give safely, although we know there are some serious side effects."

The National Surgical Adjuvant Breast and Bowel Project, based at AGH, is studying whether combining Avastin with chemotherapy would benefit women with breast cancer. The trial also is studying side effects and whether the drug affects women's recovery from breast surgery.

Raymond said she expects further research into Avastin and hopes the FDA will someday reverse its decision. Until then, she said, "I have a lot of disappointed patients, and I know a lot of disappointed oncologists."

Avastin will remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer. Breast cancer patients can still use it, but without FDA approval, insurers may not cover the costs. Treatment with Avastin can cost as much as $100,000, including infusion fees.

"I think if a doctor feels (Avastin) is going to provide the best benefits, patients shouldn't have to jump through hoops to get it," Needles said. "The FDA should not have the authority to override a doctor that says this is what's going to help this patient."

The National Breast Cancer Coalition supports the decision, saying there is no evidence Avastin works.

"Since 2008, NBCC has taken the position that accelerated approval for Avastin was lowering the bar on drug approval," the coalition said in a statement. "If evidence shows an approved drug has little or no benefit and harms patients, approval must be revoked. ... We must continue the search for interventions that do provide meaningful benefit that outweighs harm for women with breast cancer."

Elizabeth Thompson, president of the Susan G. Komen for the Cure foundation, said the decision "underscores the need for aggressive research."

"We know that this decision was a difficult one for the FDA and respect the length of time they spent deliberating the many issues that impact patients," Thompson said in a statement. "We want to ensure that women who are successfully using Avastin today continue to have access to the drug, and that their treatment be covered by third-party payers."

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(c)2011 The Pittsburgh Tribune-Review (Greensburg, Pa.)

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