FDA panel against use of Avastin for breast cancer

A panel of cancer experts ruled Wednesday that Avastin - the world's best-selling cancer drug, developed by Genentech in South San Francisco - should no longer be used in breast cancer patients because of concerns the medicine didn't work as well in follow-up studies and may cause deadly bleeding.

Outside advisers to the Food and Drug Administration voted 6-0 against Avastin's use in breast cancer at a first-of-its-kind hearing in Silver Spring, Md. Their recommendations will be sent to FDA Commissioner Margaret Hamburg, who will make the final ruling on an unspecified date. Avastin will remain on the market because it's approved for four other types of tumors.

The decision capped two days of testimony from patients urging the panel to continue access while FDA scientists argued the drug is too dangerous. A final ruling is at least weeks away while the agency takes comments from the public through July 28. Doctors can prescribe Avastin "off label" in breast cancer even if approval is withdrawn, though insurers may no longer pay the $8,100-a-month price tag.

"There are just so many questions here and the agency has to look at protecting a larger number of patients," said panel member Ralph Freedman, a clinical professor at the University of Texas M.D. Anderson Cancer Center in Houston.

The panel took a little more than an hour for its deliberations, less than half of the time allotted by the FDA. The advisers also voted unanimously that Avastin didn't have benefits in breast cancer and that its risks weren't justified.

Avastin also is used to treat lung, kidney, colon and brain cancer. Approval for those uses won't be affected by Wednesday's recommendation. Global sales last year were $6.22 billion, or 14 percent of revenue for Roche Holdings AG, Genentech's parent company based in Basel, Switzerland.

"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove an important medicine for women with this incurable disease who already have too few treatment options," Charlotte Arnold, a spokeswoman for Roche, wrote in an e-mail. "We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin."

The FDA gave Avastin accelerated approval for breast cancer in February 2008, overruling its advisory panel, on the basis of one study that suggested the medicine, combined with chemotherapy, slowed tumor growth by 5 1/2 months. Required follow-up tests found Avastin kept cancer at bay for one to two months. The drug was also tied to more life-threatening side effects such as severe bleeding, stomach tears and high blood pressure.

The FDA moved to withdraw Avastin's approval in breast cancer on Dec. 16 with the support of the advisory panel. Roche appealed the proposal, leading to this week's hearing.

"We all wanted Avastin to succeed, but the reality is that in these studies that we're talking about, it did not," said Natalie Compagni-Portis, the panel's patient representative from Oakland.

About a dozen patients and family members in the audience began shouting and crying after the vote, saying they'd depended on Avastin for years and had no other treatment options.

This article appeared on page D - 1 of the San Francisco Chronicle