• 21
  • November
    2011

Breast cancer sufferers and research advocates received a blow this week when federal regulators revoked approval of the drug Avastin for use in treating metastatic breast cancer.

According to the Food and Drug Administration, the drug-which had brought in $6.2 billion in 2010 sales-had no positive effect in prolonging patients' lives and actually brought about significant side effects, including increased blood pressure and bleeding.

While the drug may no longer be used to treat metastatic breast cancer, it remains approved for the treatment of colon, lung, kidney and brain cancer. Pharmaceutical Roche AG estimates the lack of approval may put $873 million in revenue at risk.

Regulators said the decision to withhold approval was difficult since many had hoped Avastin would be an improvement on other drugs on the market. The agency has the duty, though, of ensuring that drugs are both safe and effective for their intended use.

According to the American Cancer Society, roughly 230,480 American women will be diagnosed with new cases of metastatic breast cancer this year and an estimated 39,530 will died from the disease. The decision will, no doubt, cause insurers to take another look at Avastin coverage policies and doctors to reconsider whether Avastin is beneficial for their patients. Those who are benefitting from it may be advised by their doctors to continue taking it.

Roche, who doesn't appear to be appealing the decision, will continue to study the drug and see whether there are any breast cancer patients who could benefit from the drug.

Source: Businessweek, "Roche's Avastin Revoked for Use in Breast Cancer, FDA Says," Anna Edney, November 18, 2011.