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Avastin vote has limited implications, specialist says

E-mail | Print | Comments () Posted by Elizabeth Cooney July 22, 2010 03:37 PM

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A cancer-fighting drug based on theories advanced by the late Dr. Judah Folkman was dealt a blow this week by a federal advisory committee reviewing its use in breast cancer, but that doesn’t necessarily carry over to other cancers or other drugs in it class, a member of his Boston lab said.

A panel convened by the US Food and Drug Administration voted by a 12-to-1 margin to revoke approval of Avastin for women with late-stage breast cancer. In 2008 Avastin won accelerated approval for women with a specific type of advanced breast cancer.

Early studies had shown that women with HER-2 negative breast cancer who took Avastin and the chemotherapy drug paclitaxel (Taxol) went about five months longer without their tumors growing than women who took paclitaxel alone. The FDA’s approval was granted with the expectation of another vote once more was known from longer studies about how well it worked. Two later studies from Avastin's manufacturer did not show the same benefit as the initial one.

“What the FDA would be saying is ... for women with breast cancer, Avastin with paclitaxel was not better than paclitaxel alone. It doesn’t mean the drug wouldn’t work for other types of breast cancer or with other types of chemotherapy. Or for other types of cancer,” said Dr. Mark Kieran, who studies vascular biology in Folkman’s former lab at Children’s.

Avastin has full FDA approval for colon, lung, and kidney cancer and accelerated approval for brain cancer.

Kieran is also a pediatric neuro-oncologist at Dana-Farber Cancer Institute. He does not treat women with breast cancer, but advised caution for women wondering what to do while FDA weighs its advisory panel’s recommendation. The agency is not obligated to abide by the panel's vote, but it often does. A decision is expected by Sept. 17.

“I wouldn’t recommend that women with breast cancer stop taking their Avastin. I think this is a decision between breast oncologists and women,” once FDA makes its decision, Kieran said.

Avastin is just one drug that attacks one protein involved in angiogenesis, or the building of blood supply. There are about 40 molecules that tell the blood system to make new blood vessels, he said. Folkman pioneered the idea that tumors could be blocked by cutting off their blood vessel growth.

“This is not a blanket withdrawal of all these drugs,” Kieran said.

Genentech echoed that conclusion.

"We are disappointed by the committee's recommendation and believe Avastin should continue to be an option for women with this incurable disease," Dr. Sandra Horning, Genentech senior vice president, said in a statement Wednesday. "We will continue to discuss the data from the more than 2,400 women who participated in three Phase III studies with the FDA. This recommendation does not impact Avastin's approved uses for other cancer types."

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About white coat notes

White Coat Notes covers the latest from the health care industry, hospitals, doctors offices, labs, insurers, and the corridors of government. Chelsea Conaboy previously covered health care for The Philadelphia Inquirer. Write her at cconaboy@boston.com. Follow her on Twitter: @cconaboy.

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