The Burrill Report


A unanimous vote by a U.S. Food and Drug Administration panel supported the agency’s proposal to revoke approval for the use of Genentech’s Avastin in treating advanced breast cancer after clinical trials called into question the effectiveness and safety of using the drug to treat women with the cancer.

In a series of 6-0 votes, the Oncologic Drugs Advisory Committee ended a hearing that has generated passionate debate between patient advocates, scientists, lobbyists, and lawyers, all fighting over the agency’s decision to turn back a provisional approval of the drug’s use in the disease.

Genentech and some patient advocates believe the drug can be beneficial for women with metastatic breast cancer. They implored the FDA panel not to roll back an accelerated approval granted in February 2008, which was based on a trial showing that the drug could extend the lives of women with HER2-negative late-stage breast cancer who had not received chemotherapy.

Later trials, however, suggested otherwise. Those trials showed the drug failed to prolong overall survival in breast cancer patients, and failed to provide a sufficient benefit in slowing the cancer to outweigh the drug’s risks. Those risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations in the body, and heart attack or heart failure.

In the course of voting to support the FDA’s plans to revoke its earlier approval for the use of Avastin in treating breast cancer, the agency rejected a compromise proposal made by Genentech that would have maintained the approval while the company conducted further trials.

“We all want better treatment for women with this disease,” says Breast Cancer Action, a San Francisco-based patient advocacy group. “Unfortunately, Avastin is not that treatment.”

Avastin remains approved for use in treating lung, kidney, and brain cancers. The FDA granted the drug a conditional approval for treating breast cancer in Feburary 2008 as part of a program intended to allow earlier patient access to drugs for serious or life-threatening conditions while further research is done to back their safety and efficacy.

Global sales of Avastin during 2010 totalled $6.22 billion, or about 14 percent of the revenue for Genentech’s parent company, Roche. Losing Avastin’s breast cancer indication could cost the company as much as $1 billion a year, according to analysts. To protect the product, the company reportedly deployed numerous lobbyists and lawyers in Washington to argue its case.

With the committee’s advisory vote complete, FDA commissioner Margaret Hamburg will now make a final decision on whether the agency will revoke Avastin’s approval for treating breast cancer or not.


June 30, 2011
http://www.burrillreport.com/article-a_billion_dollar_no_vote_for_genentech.html