The drug Avastin should no longer be used to treat breast cancer, the Food and Drug Administration (FDA) said today.
The agency cited evidence that the drug is not safe nor effective in treating breast cancer. Recent studies have shown that patients who took Avastin lived no longer than those who didn't take the drug.
In addition, Avastin has serious side effects, including severely high blood pressure, bleeding and hemorrhage, and the development of perforations (or holes) in the stomach and intestines.
The announcement comes after several advisory panels to the FDA recommended the drug not be used to treat breast cancer . FDA Commissioner Dr. Margaret A. Hamburg was in charge of making the final decision.
"I did not come to this decision lightly," Hamburg said today at a news conference. However, after reviewing the existing evidence, "It is clear that there is no proof of a benefit in breast cancer patients that would justify [the drugs'] risks," Hamburg said.
The drug is still approved to treat colon, lung, kidney and brain cancer.
In 2008, Avastin, made by Genentech Inc., received fast-track approval to treat advanced breast cancer after initial studies suggested the drug could reduce tumor growth. As part of the decision to approve the drug, the FDA said further studies would need to be conducted to confirm the benefit.
"Unfortunately, the additional studies failed to confirm Avastin's initial promise," Hamburg said.
Genentech has said there may be subgroup of women who benefit from the drug more than others. Hamburg said the FDA encourages the company to pursue studies that could provide evidence of this, and would be open to re-considering approval of the drug once such studies have been conducted.
The FDA cannot prohibit people from taking the drug. Ultimately, the decision of whether to use Avastin for breast cancer rests with the patient and his or her doctor. Hamburg said she encourages patients to discuss the risks and benefits of the drug with their oncologist.
Pass it on: The FDA is revoking its approval of Avastin as a treatment for breast cancer.