HEALTH -- December 16, 2010 at 1:53 PM ET
FDA: Avastin Does Not Work for Breast Cancer Treatment
(Photo by Jb Reed/Bloomberg via Getty Images)
The Food and Drug Administration said Thursday that it is beginning the process of revoking approval for the drug Avastin for use in the treatment of breast cancer.
In a statement, the agency said that four independent trials have shown that Avastin does not increase life expectancy for breast cancer patients and that it has serious side effects, including high blood pressure, bleeding and hemorrhaging, holes in the intestines and stomach, and heart failure.
"The limited effects of Avastin combined with the significant risks led us to this difficult decision," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
The FDA approved Avastin in 2008 using a fast-track accelerated approval program after one large study found that the drug could increase "progression-free survival time" -- or the amount of time a breast cancer patient lived before cancer got worse -- by five months on average. But follow-up trials failed to find the same effect, or to show that the drug increased life expectancy.
The move is not a surprise -- an independent panel advised the FDA in July to take Avastin off the list of drugs approved to treat breast cancer.
But it has aroused opposition from some patient groups. In a statement Thursday, the Susan G. Komen for the Cure foundation urged insurers to keep paying for Avastin, which can cost close to $90,000 per year.
"We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug's manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program," foundation president Elizabeth Thompson said.
But other cancer groups expressed support for the decision.
"Clearly some women with metastatic breast cancer have benefitted from Avastin, but others not only have not benefitted, they've been harmed," Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society," said in a statement. "What we clearly need is a way for doctors to more accurately predict which women will have a better chance of benefitting from this important targeted therapy. Until that tool is developed, giving all women with metastatic breast cancer Avastin may harm more women than it helps."
Avastin will remain on the market, because it will remain approved to treat kidney, colon and other cancers. So doctors will still be able to prescribe it for breast cancer as an "off-label" use, but insurers will be less likely to pay for the treatment. Genentech/Roche earns about $6 billion per year from sales of Avastin; analysts estimate that about $1 billion of that comes from breast cancer treatment.
Thursday's announcement is the beginning of a process to remove approval. Genentech now has 15 days to request a hearing, which the company said in a statement that it will do.