Product Liability

Breast cancer indication for Avastin still a ‘no’

Breast cancer survivors pleaded to a Food and Drug Administration (FDA) panel of experts earlier this week to keep the breast cancer indication for the drug Avastin (bevacizumab). Avastin is used for the treatment of colon, kidney, brain and lung cancers. Late last year, the FDA voted to remove the breast cancer indication from the drug because it did not prove safe and effective in studies among patients with breast cancer.

The FDA’s recommendation is based on the results of four clinical studies of Avastin in women with breast cancer. The FDA found that the data from those studies indicated that Avastain does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing the disease progression to outweigh the significant risk to patients.

In fact, the data showed that patients who took the drug didn’t live longer than patients who did not take the drug. Furthermore, patients taking Avastin also experienced a significant increase in serious side effects that included severe high blood pressure; bleeding and hemorrhage; the development of perforations in the body; and heart attack or heart failure.

But 66-year-old breast cancer survivor Patricia Howard would beg to differ. “I never thought that in the United States, I would have to beg for a drug that is keeping me and many others alive,” she told the FDA panel. “Please approve Avastin treatment for my disease.” Howard was diagnosed five years ago with advanced breast cancer. She has been taking Avastin and was recently declared cancer-free by her doctors.

Following the two-day public hearing in which both supporters of the FDA action to remove the breast cancer indication for Avastin and those wanting it to stay had their say, the panel voted to support the action to revoke the breast cancer indication for the drug.

Since the drug will still be on the market, doctors can still prescribe it for indications that are not listed on the safety label. However, many insurance companies would likely refuse to pay the near-$90,000 for a treatment not approved by the FDA. In January, Palmetto GBA, a large Medicare provider, said it was taking steps to no longer cover Avastin as a breast cancer treatment.

The fight is not over, however. Public comments will be accepted until July 28. The final decision on the drug’s fate is in the hands of FDA commissioner Dr. Margaret Hamburg. There is no date as to when Dr. Hamburg will make that decision.