US panel rejects Avastin for breast cancer use

An expert panel urged the US Food and Drug Administration to strip the Roche-made drug Avastin of its label for use against breast cancer because it is neither safe nor effective.

After a rare two-day appeal hearing by Genentech, a US unit of the Swiss pharmaceutical giant, the panel voted 6-0 to uphold its earlier recommendation in December to stop the use of Avastin for breast cancer.

The drug, also known as bevacizumab, carries risks such as severe high blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer, the panel said.

A final decision by the FDA commissioner must be issued, but will not likely come before the end of July. The FDA does not have to follow the recommendations of the expert panel but it usually does.

The docket will remain open until July 28 for public comment, and a final decision will follow, though an exact date has not been announced.

“The commissioner’s decision related to breast cancer will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers,” the FDA said.

Some members of the public, including women dressed in pink who carried signs that read: “I am more than a statistic” had clustered outside the FDA building where the hearing took place, according to media reports.

Breast cancer patients who were taking Avastin were allowed to talk about their experiences.

Afterward, Terry Kalley, founder of Freedom of Access to Medicines, said he was disappointed, but not surprised, with the decision.