FDA Votes to Withdraw Avastin Approval as Late-Stage Breast Cancer Treatment
The Food and Drug Administration (FDA) has recommended that Avastin – currently the world’s best-selling cancer drug – no longer be used to treat breast cancer. This decision reverses a temporary approval for the drug in 2008 after research showed that women on a pharmaceutical regimen including Avastin lived an average of two to three months longer than patients without it.
The controversy surrounding this latest decision has been fierce, and shows no sign of fading. The FDA claims its reversal is because four recent studies show the drug does not help slow the spread of breast cancer, doesn’t prolong survival, and has serious side effects that outweigh the drug’s benefits. Side effects include severe high blood pressure, bleeding and hemorrhage, the development of perforations in the nose, stomach, and intestines, and heart attack or heart failure.
Supporters of Avastin, on the other hand, claim that the FDA’s decision has more to do with cost than care. Medicare, Medicaid, and private insurers typically pay a substantial portion of the cost of Avastin, which can total upwards of $90,000 for a year of treatment.
Despite the controversy, it is important to know that Avastin itself is not being removed from the market. The drug’s approval for use in treating colon, kidney, brain, and lung cancers remains in effect. According to the FDA, removing the breast cancer indication from the Avastin label will be a process, and oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue using the drug or consider other options.
For perspectives on both sides of the Avastin issue, visit:
