FDA Panel Says No to Avastin for Advanced Bre... ( Drug has significant risks and its be...)

FDA Panel Says No to Avastin for Advanced Breast Cancer

Date:12/5/2007

Drug has significant risks, and its benefits are still debated, experts say

WEDNESDAY, Dec. 5 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that the cancer drug Avastin should not be used to treat women with advanced breast cancer.

In a close vote, 5-4, the advisers decided the drug's ability to slow down the growth of tumors did not outweigh the increased risk of blood clots and other cardiovascular troubles among users, the Associated Press reported. In rare cases, patients taking Avastin with standard chemotherapy have died.

Avastin was approved to treat colon cancer in 2004, and lung cancer in 2006. It works by cutting off the tumor's blood supply.

"Everybody wants to offer metastic breast cancer patients hope, but we shouldn't offer them false hope," panel member Natalie Compagni-Portis, a patient representative with Breast Cancer Action in San Francisco, said during the meeting, according to the AP. "We have to raise the bar in terms of safety."

"These patients are terminal, and it's our job to make their lives better, not to say that it's OK to have a stroke or that it's manageable," Maha Hussain, an oncologist at the University of Michigan and the advisory panel's chairwoman, said during the meeting. "You didn't show that patients are living better or that they're living longer."

In trial results submitted to the FDA by the drug's U.S. maker, Genentech Inc., use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with the chemotherapy drug paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.

However, the same Genentech study of 722 patients showed that patients reaped no gain in terms of their overall survival after taking Avastin.

Another company-funded trial, this ti
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