Breast Cancer Health Center

FDA Mulls Fate of Avastin as Breast Cancer Drug

Accelerated Approval Program

In December 2010, the FDA announced that it would withdraw its conditional approval as a treatment for breast cancer.

Genentech, the company that makes Avastin, is appealing that decision and has taken the rare step of requesting a public hearing. The company will present its case tomorrow.

Today, regulators took pains to lay out the evidence they used to conclude that Avastin should no longer be prescribed for breast cancer.

"The totality of the data show that the Avastin has only a modest effect on PFS [progression-free survival], and this small effect, in the absence of an effect on overall survival or patient quality of life, does not outweigh its substantial and life-threatening risks," says John K. Jenkins, MD, director of the office of new drugs at the FDA's center for drug evaluation and research.

Jenkins called withdrawal "the right public health decision."

If the FDA sticks by its withdrawal of Avastin's approval for breast cancer, the drug, which can cost as much as $100,000 a year, will remain on the market, but insurance companies are less likely to cover it for that use.

Breast cancer patients would also lose access to the drug through the company's patient assistance program, which caps the drug's annual cost at about $58,000.

Since 1995, Jenkins says, the FDA has granted 49 indications for cancer drugs through its "accelerated approval" process.

At least three of those drugs failed to show clinical benefit and later had their approvals revoked.

The FDA reported in a study published in March in the Journal of the National Cancer Institute that 14 other drugs have failed to complete the required confirmatory trials.

Some of those drugs have been allowed to remain on the market for more than 10 years without any additional evidence to back up their safety and efficacy, a fact the FDA says undermines the integrity of the accelerated approval program.

Genentech has asked the FDA to keep Avastin available for breast cancer while it conducts another study.

In response, Jenkins says the agency can't allow "protracted marketing of drugs that have not been shown to be safe and effective while sponsors take numerous bites at the apple in an effort to confirm clinical benefit."