Experts Speak Out: FDA Ruling on Avastin

Feb. 22, 2008— -- The Food and Drug Administration is expected to decide in the next few days whether to approve Avastin for the treatment of breast cancer.

When an FDA committee voted 5-4 against approving the drug in December, ABCNEWS.com invited breast cancer experts to comment on whether they agreed or disagreed with this decision.

All but one of the breast cancer experts who responded both in December and Thursday said that they disagreed with the FDA's decision not to approve Avastin for the treatment of breast cancer. The Wall Street Journal reported Wednesday that two members of the FDA advisory panel who'd voted against approval had tried to change their votes to yes, tipping the balance toward recommending approval.

The study that Genentech, Avastin's manufacturer, submitted to the FDA found that using Avastin in combination with Taxol, a breast-cancer drug made by Bristol-Myers Squibb Corp., delayed the growth of patients' tumors for 11.3 months -- 5.5 months longer than Taxol alone.

But despite this, the study found that the women on Avastin didn't live significantly longer than those on Taxol, and they experienced more bad side effects, such as high blood pressure, blood clots and bowel perforation. Moreover, six deaths were linked to Avastin's toxicity.

Avastin works by replicating the body's own weapons -- antibodies that block the growth of blood vessels that feed tumors.

Breast cancer is a curable disease, but once it has metastasized it is considered treatable but not curable. An estimated 45,000 women die of metastatic breast cancer each year. Of those, Genentech estimates that 38,000 have tumors that might respond to Avastin.

In light of the upcoming decision, we have asked these experts to weigh in once again on whether they support approval or not.

Though breast cancer experts remain divided over this issue, many favor approving Avastin to treat breast cancer.

PRO

"If I had voting power, my vote would be 'yes.' Patients are anxiously awaiting the opportunity to take this drug, having seen its benefits in clinical trials," said Lillie Shockney, a registered nurse and administrative director of the Johns Hopkins Avon Foundation Breast Center.

"Imagine a woman with metastatic breast cancer started her therapy mid-year 2007 ... on Avastin she would be still OK for a few months; regardless, she will die before next Christmas, but this way, you gave her another symptom-free holiday," said Dr. Stefan Glück, associate division chief of clinical affairs in the Division of Hematology/Oncology and clinical director of the Braman Family Breast Cancer Institute at the University of Miami. "I consider myself a patient's advocate. ... This is what I would think patients want to have."

"I was exceptionally disappointed," with the decision not to approve Avastin, said Dr. George Sledge, professor of oncology at the Indiana University School of Medicine. "It will definitely hamper the future development of therapies for advanced breast cancer. It is particularly disappointing given that the FDA has approved, in recent months, a far more toxic agent for breast cancer based on a far less positive study."

CON

"I would have voted against approval," said Dr. Anthony Elias, director of the Breast Cancer Research Program at the University of Colorado Health Sciences Center. "One trial that is negative and one trial [that is] positive does not give a clear answer."