Avastin for breast cancer now in doubt

An advisory panel of the FDA voted unanimously to

withdraw approval of Avastin for advanced breast cancer.

WASHINGTON, D.C. – July 20, 2010 – An FDA advisory panel recommended today that the approval of Genentech’s Avastin® (bevacizumab) be withdrawn for the treatment of advanced breast cancer. The recommendation came following results of a pair of studies that failed to confirm earlier results.

The recommendation does not affect the status of Avastin for the treatment of lung, colon and brain cancers.

In 2008, the FDA gave Avastin accelerated approval in combination with paclitaxel to treat advanced breast cancer based on a study showing the treatment extended the progression-free survival by five months, meaning tumors in women taking the combination treatment stopped growing on average five months longer than women treated with paclitaxel alone. The FDA granted the approval at that time on condition that additional studies confirm those findings.

The results of two subsequent clinical research studies completed recently involving more than 2,000 breast cancer patients, however, only showed a modest one month longer progression-free survival compared to patients treated with paclitaxel alone. The panel also found that the added side effects of Avastin outweighed the benefits, and voted 12-0 to advise against final approval of Avastin for breast cancer treatment.

Avastin was the first drug approved by the FDA designed to block the process of angiogenesis or blood vessel growth. It is among a new family of targeted therapies that specifically zero in on protein characteristic specific to tumors. In this case, the drug blocks the vascular endothelial growth factor (VEGF), which cuts off the growth of new blood vessels tumors need for continuous growth.

Genentech strongly disagreed with the panel’s decision and maintained that the drug can improve the lives of women with advanced breast cancer.
"We are disappointed by the committee's recommendation and believe Avastin should continue to be an option for women with this incurable disease," said Dr. Sandra Horning, senior vice president, global head, Clinical Development Hematology/Oncology. "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."
The recommendation also does not impact the use of Avastin for advanced breast cancer in other countries.
SOURCE: press materials provided by Genentech, Inc.