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Health Canada reviewing cancer drug

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OTTAWA -- Health Canada is actively reviewing the drug Avastin to determine whether the benefits outweigh the risks as a treatment for advanced breast cancer.

The U.S. Food and Drug Administration revoked its approval for the drug for patients with metastatic breast cancer Friday because there's no proof that it extends lives or provides enough temporary benefit to outweigh dangerous side effects.

The Canadian agency said it is aware of the FDA decision, and will consider it and information from the manufacturer in making its final decision.

"Health Canada will inform healthcare professionals and Canadians of any changes with respect to the status of Avastin once the review of Avastin has been completed," spokesman Gary Holub said in a statement.

"At this time, Health Canada has not arrived at final conclusions or recommendations regarding Avastin; Avastin continues to be available as a treatment for breast cancer in Canada."

Avastin's approval also remains in place for certain types of colon, lung, kidney and brain cancer, said Holub.

Dr. Eitan Amir, a medical oncologist at Princess Margaret Hospital in Toronto, indicated that very few Canadians are using the drug for advanced breast cancer because no provinces have approved funding for it.

"So I think the number of women receiving this medication outside of a clinical trial is probably going to be pretty small, and limited to some self-paying patients," he said in an interview Friday.

Farah Meghji, manager of corporate affairs for Roche Canada, said the drug was approved in Canada in 2009 for use in patients with breast cancer that has spread.

She couldn't provide information on sales of Avastin in Canada, but confirmed that it's not currently funded by any of the provinces.

Those who are using the drug would be part of a clinical trial or would be accessing the drug through private insurance companies, or paying cash, she said.

The cost would vary, depending on the weight of the patient, and the number of cycles, she noted.

The ruling by the FDA was long expected, but it was certain to disappoint women who say they've run out of other options as their breast cancer spread through their bodies. Impassioned patients had lobbied furiously to preserve Avastin as a last shot.

"We are disappointed -- we do know that there are patients experiencing benefit from the product," Meghji said from Mississauga, Ont.

"Those are the patients that unfortunately will be affected by it (the FDA decision)."

Repeated studies found the drug had only a small effect on tumour growth.

The research didn't show evidence that patients lived any longer or had a better quality of life than if they had taken standard chemotherapy. The FDA concluded that the drug presented an array of risks, including severe high blood pressure, massive bleeding, heart attack or heart failure, along with perforations in the stomach and intestines.

"I did not come to this decision lightly," said FDA commissioner Dr. Margaret Hamburg. But, she said, "sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing."

Avastin is the world's bestselling cancer drug, and is also used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it -- but insurers may not pay for it. Including infusion fees, a year's treatment with Avastin can cost $100,000.

Some insurers had already quit covering the drug's use in breast cancer after FDA's advisers twice -- once last year and once this summer -- urged revoking the approval.

-- The Canadian Press

Republished from the Winnipeg Free Press print edition November 19, 2011 A22

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