Another Potential Setback for Anti-Cancer Drug Avastin

Washington, DCOn the heels of a ruling by the US Food and Drug Administration (FDA) in December, noting that Avastin should not be used by breast cancer patients, comes an analysis that suggests the anti-cancer drug is linked to fatal side effects in about one percent of the patients who take it.

CNN Health reported last night that a meta-analysis studying the results of 16 unique trials involving Avastin revealed various issues with an anti-cancer drug that has already been the subject of some controversy.

For example, while Avastin had been approved for the treatment of various forms of cancer—including cancers of the lung, colon, kidney and brain—the FDA decreed in December that in its view the risks associated with use of Avastin in breast cancer patients outweighed what were described as modest benefits.

And yet, in the studies used for the most recent meta-analysis, the rate of fatal adverse events for breast cancer patients was lower for the Avastin group.

The manufacturer of Avastin, Genentech, appealed the FDA ruling in January.

The study, published in a recent edition of the Journal of the American Medical Association, compared the rate of fatal adverse events for patients on chemotherapy alone, with the rate for patients taking the drugs in combination with Avastin (bevacuzimab). In the chemotherapy group, 1.7 percent of patients suffered fatal side effects; while in the Avastin/chemotherapy group that number was 2.5 percent.

The most common serious side effects were internal bleeding and infection due to low white blood cell count.

According to the studies, while Avastin may slow the worsening of symptoms for breast cancer patients, at the same time it has been found that Avastin does not extend survival for breast cancer patients.

As for the studies used for the meta-analysis, a spokesperson for the Avastin manufacturer noted that the new meta-analysis included the deaths of patients suffering from squamous cell lung cancer—a type of cancer for which Avastin is not approved.

And a lung cancer specialist with the University of Colorado School of Medicine noted that doctors are already aware of the risks associated with Avastin. "In lung cancer," said Dr. Paul Bunn, "where you improve survival by a relatively large amount—about two and a half months [on average]—this kind of risk is fine. But when there's zero effect on actual survival, then that is a factor."

Doctors have always possessed the moral, legal and professional authority to prescribe dugs off-label for indications not approved by the FDA. Dr. Bunn said that in the face of emerging information regarding Avastin, doctors need to carefully weigh the advantages and potential drawbacks of Avastin for each patient.