FDA advisors reject Avastin as breast cancer treatment

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A panel of advisors to the Food and Drug Administration voted 6 to 0 to halt the use of the cancer drug Avastin for the treatment of breast cancer, saying studies have failed to show Avastin is effective for that purpose.

The recommendation Wednesday came after two days of testimony from patients, doctors and advocacy groups. The panel heard several tearful accounts, like that of Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday.

“I’m a testament that the drug does work.... I’m not just a statistic,” she said. “Keep breast cancer on the label so that I and others like me can celebrate more birthdays.”


Advisors acknowledged the emotional nature of the issue, but said the science should prevail. “I think we all wanted Avastin to succeed,” said Natalie Compagni-Portis, a member of the committee. Studies, however, “didn’t bear out that hope,” she said.

The drug will remain on the market for other cancer treatments, but an FDA withdrawal would probably mean insurance companies wouldn’t cover it for breast cancer patients. As a result, many women wouldn’t be able to afford the treatments, which can cost up to $100,000 a year.

Though the FDA will make the final decision, it rarely ignores recommendations of its advisors. One of the rare instances was in 2008, when the agency approved Avastin for breast cancer treatment. The decision came under the agency’s accelerated approval process, which fast-tracks potentially life-saving drugs on a conditional basis.

Approval was based on a single study by the manufacturer, which suggested the drug prevented the disease from advancing for an average of 5.5 months. But subsequent studies have failed to replicate the results, and have shown the drug carries serious risks, such as high blood pressure, heart attacks and bleeding.

“We are very disappointed by the committee’s recommendation,” said Krysta Pellegrino, a spokeswoman for Genentech, which is based in South San Francisco. The company has successfully marketed Avastin as a blockbuster drug for treating colon, lung and brain cancers.