FDA panel rejects Avastin use for breast cancer
Washington, June 30, 2011
US health advisers unanimously rejected use of the drug Avastin for breast cancer, dealing a blow to its manufacturer and patients who insisted that the medicine saved their lives.
Advisers to the US Food and Drug Administration agreed that the Roche Holding AG drug was not safe or clinically beneficial, based on several years of follow-up trials.
Their vote endorsed an FDA move in December to revoke its approval for Avastin in breast cancer. FDA Commissioner Margaret Hamburg is due to make a final decision later.
"No matter what way we look at it, there's nothing we can hang our hat on in these studies that would make me feel comfortable continuing to expose a lot of patients to risk without a clear benefit," said Mikkael Sekeres, associate professor of medicine at the Cleveland Clinic Taussig Cancer Institute and one of the panel members.
Patient advocates broke down in tears after the vote in an emotional conclusion to the rare two-day hearing. Without FDA approval, insurers and government health programs likely will stop covering the $8,000-a-month drug, potentially jeopardising treatment for an estimated 17,000 women using the medicine.
"I'm on Avastin alone, so it's not the chemo that's keeping me alive," said Christi Turnage, 49, who stood up among a handful of breast cancer patients after the vote, shouting at the panel members and crying.
Turnage said she has been taking Avastin for eight years, but that her insurance plan had warned her they would drop coverage if it is rejected by the FDA. She cannot afford it on her own.
"Trial or no trial, we have nothing. I don't even qualify for a single (drug) trial in the United States or Canada because I have no symptoms of disease," she said. - Reuters