A crucial vote Wednesday at the food and drug administration could affect thousands of women suffering from advanced breast cancer.
FDA advisors said there's no solid evidence the popular breast cancer drug, Avastin, is safe or effective against breast cancer and should not be approved to treat it.
It has been science versus emotion in the debate over whether Avastin should be used to treat breast cancer. Dr. Mikkael Sekeres, an FDA Panel Member, said there was simply no proof that Avastin extended lives.
At the hearings in Maryland, women stood up in peaceful protest of the FDA advisors' vote – 6 to 0 – to revoke approval of Avastin for breast cancer.
"Lack of evidence is lack of evidence. There's no survival benefit with Avastin," Dr. Sekeres said.
However, in two days of testimony, some breast cancer patients swore that their lives were saved by the drug.
Breast cancer patients like Castaic resident Matilde Singer said she can understand the emotions of the patients who testified.
“When I was first diagnosed and I think it’s the case with most cancer patients. They would do anything,” Singer said.
Burbank Breast Cancer Surgeon Deanna Attai says this decision, if approved by the FDA Commissioner, will affect how doctors treat patients with aggressive breast cancer.
“Well, we have one less option for patients who don’t have very many options… You just can’t ignore the fact that there are some very serious side effects with this medication and some potentially fatal side effects,” Attai said.
The drug was given fast-track approval in 2008 for breast cancer only if the drug maker, Genentech, follow up with studies that showed it was safe and effective. The drug maker proposed conducting a new study.
"We are willing to work with the FDA to find a solution, such as a modified or restricted label," said Dr. Hal Barron, Genentech Chief Medical Officer.
The FDA panel's vote on Avastin will not be final until the agency's commissioner makes an official ruling -- expected within the next month.
“What would be ideal is if there could be markers developed, or some sort of way to determine, are you likely to respond to Avastin, and then if so, it is absolutely in most situations, probably going to be worth the risks of the drug,” Dr. Attai said.
However, that kind of research could be a long ways off. If Avastin is not approved for breast cancer -- it will still be available but will likely not be covered by insurance... And can cost patients an estimated $90,000 a year.
