FDA pulls plug on breast cancer drug

WASHINGTON, Dec. 16 (UPI) -- U.S. federal regulators said Thursday they were going to revoke approval of the widely-used drug Avastin for use in treating patients with breast cancer.

The Food and Drug Administration announced plans to withdraw authorization to sell Avastin for metastatic breast cancer treatment, saying four new studies indicate the benefits of the drug in such cases does not outweigh the risks, The Washington Post reported.

Avastin has global sales of $5.8 billion, and is the top-selling product for Hoffmann-La Roche, one of the largest pharmaceutical companies in the world.

Its use to treat breast cancer brings in about $855 million in annual revenue in the United States.

"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said.

"None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision."

The FDA said Genentech, the Hoffman-La Roche unit that makes the drug, had 15 days to request a hearing to review the decision.

The company said in a statement it would immediately request that step.

Avastin, prescribed to about 17,500 breast cancer patients each year, remains approved to treat several other cancers, including those of the colon, lung, kidney and brain, the Post reported.