FDA Revokes Approval of Breast Cancer Drug Avastin

The agency’s commissioner says the drug’s side effects are life-threatening.

The FDA announced today that it is revoking its approval of Avastin for breast cancer treatment, saying it has not proven to be safe or effective for that type of cancer.

FDA Commissioner Margaret A. Hamburg said Avastin’s risks were too extreme and life-threatening to allow patients to continue taking it. Symptoms include severe high blood pressure, bleeding and hemorrhaging, heart attack or failure, and damage to the nose, stomach, and intestines, among other body parts.

The agency approved Avastin to treat metatastic breast cancer in February 2008. However, it was approved through the FDA’s accelerated-approval program, which allows patients access to new drugs that show promise even though clinical trials for the drug are still ongoing.

Results from a few clinical trials found that the use of Avastin only had a small effect on patients’ tumor growth and did not prove to be a better treatment than chemotherapy.

The drug is still approved as a form of treatment for colon, lung, kidney, and brain cancer.

For more information on the FDA’s decision, click here.