- The Washington Times - Saturday, February 23, 2008

ASSOCIATED PRESS

A Genentech drug received federal approval yesterday to treat breast cancer, a surprise decision that could represent a shift in standards for assessing the effectiveness of cancer medicines.

Going against the recommendation of its advisory panel, the Food and Drug Administration judged the effectiveness of Avastin based on measurements of tumor growth, not patient survival.

The ruling prompted a mixed reaction from both doctors and advocates for breast cancer patients.

Some bemoaned the lowering of medical standards, but others applauded the federal government’s endorsement of a drug that is already prescribed “off-label” to an estimated 9,500 patients and for whom insurance coverage is limited.

Avastin, which is already approved in the United States for treating lung and colon cancer, was Genentech’s best-selling product last year with revenue of $2.3 billion. Through a partnership with Genentech, Swiss drug maker Roche markets the drug in Europe, where it had previously been approved as a breast cancer treatment.

Many analysts expected the agency to wait until Genentech submitted more patient data and then make a decision later this year. FDA approval for drugs targeted at cancer patients who have never been treated before is usually contingent upon data showing a drug extended, or improved the quality of, patients’ lives. Avastin showed neither in a study submitted by Genentech.

Some cancer experts see FDA’s Avastin decision as opening the door for more cancer drugs to be approved for tumor-shrinking capabilities — though it could be years before another takes advantage of the access.

“It probably gives companies a wider area to operate in … to get a drug approved,” said Dr. Otis Brawley, chief medical officer for the American Cancer Society. “But I can’t think of another drug out there right now that would immediately benefit from this lower threshold.”

In December, a panel of outside FDA advisers voted 5 to 4 against the application, indicating the drug’s benefits did not outweigh toxic side effects.

Nevertheless, U.S. doctors continued prescribing it “off-label,” or without a federal endorsement. Some insurers are reluctant to pay for Avastin’s use among breast cancer patients, which can cost $100,000 for a year’s supply.

The Y-ME National Breast Cancer Organization said the approval gives patients an important new option.

“The benefits we’re looking at here matter because they give patients hope,” said Margaret C. Kirk, the group’s chief executive.

But Fran Visco, the president of the National Breast Cancer Coalition, argued that the drug’s effectiveness should not have outweighed safety risks, pointing to six deaths attributed to the drug in the study submitted to the FDA.


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