Leading Breast Cancer Drug Loses FDA Approval

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NEW YORK (MainStreet) – The U.S. Food and Drug Administration announced Thursday that it will remove its approval of Avastin, a leading breast cancer drug, arguing that it is not a safe and effective way of treating the disease.

The FDA’s decision is based on four recent clinical trials in which Avastin was found to cause severe side effects like high blood pressure, heart failure and hemorrhages, while providing only minimal effectiveness for treating breast cancer. However, this decision will not affect the agency’s approval of Avastin for treating brain, kidney and lung cancer.

“None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “The limited effects of Avastin combined with the significant risks led us to this difficult decision.”

Genentech (Stock Quote: DNA), the company that manufactures Avastin, has not agreed to stop marketing the drug as a breast cancer treatment, and will presumably appeal the agency’s decision. In the meantime, the FDA says that Avastin will continue to be sold as a breast cancer treatment, at least for the near future.

Not only is Avastin one of the most expensive drugs for treating cancer, costing tens of thousands of dollars a year, it’s also the most popular drug for breast cancer patients worldwide, with global sales totaling $5.8 billion a year. So the FDA’s decision will likely come as a particular blow to the many patients who have pinned their hopes on this treatment.

As Woodcock noted in the press release, “The results of these studies are disappointing.”

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