Panel rejects Avastin for breast cancer

If regulators follow that advice, the Swiss drugmaker could no longer promote Avastin for that use in the US.

Doctors still could prescribe Avastin for breast cancer as it would retain approval for colon, lung, brain and kidney cancers, but sales would likely fall.

Breast cancer treatment accounts for about $1bn of Avastin’s more than $6bn in annual sales, analysts said. The product is Roche’s top-selling drug.

Members of a Food and Drug Administration panel said they did not see enough of a benefit from Avastin in advanced breast cancer to justify its serious risks. They voted 12-1 to urge the FDA to remove the breast cancer approval.

The drug’s risks include gastrointestinal perforations, bleeding and blood clots.

Roche said rates of those problems were low, at less than four percent in the breast cancer trials.

But panel chairman Wyndham Wilson, a National Cancer Institute researcher, said there was definitive evidence that Avastin causes serious and life-threatening side effects. “Small numbers, but if you’re the one, that’s not what you want to be exposed to,” he said.

Overall data “does not support this being effective” in advanced breast cancer, Wilson added.

The FDA usually follows panel recommendations.

The vote was a rare setback for Avastin, a widely used treatment for a variety of cancers.

Morningstar analyst Karen Andersen said the negative ruling in breast cancer “wouldn’t be something that would change my valuation of the firm.”

“Colorectal and lung cancer are both markets where Avastin has been able to penetrate a very high percentage of the first line patients. (Roche) really relies on those indications for the foundation of Avastin sales,” she said.

Roche unit Genentech said the company stands by its data showing Avastin helps patients with advanced breast cancer. “Avastin should be an option for patients with this incurable disease,” a company statement said.

Avastin won clearance for breast cancer in 2008 under a shorter approval process, but Roche was required to run two follow-up studies to confirm the drug’s effectiveness and receive full approval.

Those studies failed to confirm the level of benefit seen in the initial breast cancer trial, FDA staff said.

Avastin, which is given intravenously, delayed the growth of cancer by 5.5 months in the initial study. In the two later studies, the time ranged from about one month to nearly three months.

Avastin did not extend patients’ overall survival in any of the studies.

The drug’s generic name is bevacizumab.