FDA advisers vote against Avastin for breast cancer treatment
WASHINGTON…A panel of advisers to the Food and Drug Administration voted 6-0 to halt the use of 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 faced 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.”
Advisers 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. “And yet what we have to do today is respond to the research that’s been presented to us…these studies didn’t bear out that hope.”
The drug will remain on the market for other cancer treatments, but the FDA’s withdrawal will likely mean insurance companies won’t cover it for breast cancer patients. As a result, many women won’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 advisers. One of the rare instances was in 2008, when the agency approved Avastin for breast cancer treatment for the first time. 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 like high blood pressure, heart attacks, and bleeding.
“We are very disappointed by the committee’s recommendation,” said Krysta Pellegrino, a spokesperson 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.
The hearing was triggered after Genentech appealed an FDA announcement in December that it would withdraw its conditional approval of Avastin for breast cancer. It’s the first hearing of its kind for therapies green-lighted under conditional approval.