FDA Advises: Avastin No Good for Breast Cancer

FDA advisory panel says Avastin's risks outweigh its benefits for breast cancer.

June 29, 2011— -- A U.S. Food and Drug Administration advisory committee today unanimously recommended that Avastin should no longer be used to treat breast cancer, saying that the risks of the drug far outweighed any benefits.

The recommendation was made after a two-day hearing that pitted the agency's Center for Drug Evaluation and Research against Genentech, Avastin's manufacturer.

"Even though we have anecdotal information, we don't have evidence that it prolongs survival or improves quality of life," said Natalie Compagni-Portis, a patient representative and voting member of the FDA panel.

In a series of four questions, the six-member panel voted across the board that the clinical trials conducted by Genentech did not provide evidence that Avastin prolonged life for breast cancer patients, nor did it improve their quality of life. The panel also recommended that FDA commissioner Peggy Hamburg should not continue to allow the drug to be used for breast cancer patients.

Following the vote, some, presumed to be breast cancer patients and their families, interrupted the hearing as they expressed their disappointment at the panel's decision.

Although a handful of patients testified Tuesday that Avastin helped in treating their metastatic breast cancer, a review of studies conducted by the FDA's Center for Drug Evaluation and Research convinced the panel that Avastin should no longer continue to be marketed as a treatment for advanced breast cancer.

Priscilla Howard, who has metastatic breast cancer, has been taking Avastin for a little more than two years and has seen a remarkable difference in the progression of her disease, she told a panel of experts at the U.S. Food and Drug Administration during the first day of the two-day hearing.

"I am progression free but not cancer free," said Howard, one of a handful of Avastin patients who gathered both inside and outside the FDA to fight for keeping Avastin on the market.

"I want every available weapon in my arsenal as I fight this devastating disease," Howard told the panel. The hearing will ultimately decide the fate of what some patients consider a lifesaving drug.

The FDA granted an accelerated conditional approval for Avastin in February 2008 to treat late-stage breast cancer patients. It had been suggested that the drug slowed the progression of the disease and improved overall survival. But results from four trials that enrolled more than 3,000 women found no significant reduction in progression of the disease or improvement of death rates among those who took Avastin and underwent chemotherapy.

"The decision must be based on the totality of evidence in all clinical trials," Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, said at the hearing Tuesday. "The totality of data submitted to FDA shows it's not safe and effective [for treating] breast cancer."

Experts who defended Genentech at the hearing suggested that Avastin coupled with the chemotherapy paclitaxel showed benefit for many patients. The manufacturers proposed conducting a new study to prove Avastin's efficacy.

"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," Genentech wrote in response to the vote. "We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin."

Doctors had previously reported seeing their patients benefit by taking Avastin, but it's not clear which patients it helps the most.

According to Dr. Daniel Hayes, clinical of the breast oncology program at the University of Michigan, further studies would have determined what types of patients would benefit from the drug.

"I fear we are throwing the baby out with the bathwater," said Hayes, who was not involved in the hearing.

The final regulatory decision rests with the FDA Commissioner Peggy Hamburg. It is unclear when the final decision will be made.

Some cancer specialists said the decision could hold huge implications for the way their patients will be treated.

American Cancer Society's deputy medical officer Dr. Len Lichtenfeld attended the hearing and tweeted Tuesday, "No one has asked the question: What do we say to all the patients and families who testified this morning?"

"Patients no doubt will feel like the FDA is putting nails in their coffin," said Lillie Shockney, associate professor of breast cancer at the Johns Hopkins University School of Medicine. "Patients feel a personal need to try to fight this disease, even if it means that only a tiny number will benefit from a particular drug. Each patient prays that they are among that tiny number."

Crystal Hanna, 35, a mother of two from Parkersburg, W. Va., said she's certain she would not be alive today if it wasn't for Avastin. Hanna, who was diagnosed with stage 4 breast cancer in July 2010, said her cancer hadn't progressed and she was still taking Avastin.

"We're not just statistics," Hanna told ABC News. "I have a lot to live for. I am here to plead with them to have compassion for our life."

Still, the FDA studies found no overall benefit from the drug, and even suggested that some patients increased their risk of death because Avastin is, in some ways, toxic.

The panel asked whether the FDA's experts who testified believed that some patients could benefit from Avastin. "No, we do not agree," Dr. Patricia Keegan, director of the FDA's Division of Biologic Oncology Products in the Office of Oncology Drug Products, said.

"Despite the hopes of everyone inside and outside this room," Keegan testified, "there is no evidence that Avastin saves or extends lives."

ABC News' Lisa Stark contributed to this report