FDA Panel Won't Support Abbott Drug

A regulatory advisory committee voted against recommending Abbott Laboratories'(ABT) cancer drug Xinlay for approval after a presentation of clinical trial data Tuesday.

The Food and Drug Administration's oncologic drug advisory committee met to review data from two of Abbott's Xinlay trials that had been submitted to support the application for the drug. Abbott is hoping to get the drug approved for treating prostate cancer in men whose disease has spread to their bones.

The FDA isn't required to vote according to the decisions of its committees, but it often does.

"Abbott respects the committee's vote on Xinlay today; however, we continue to believe that Xinlay represents an important option for patients with advanced prostate cancer who currently have limited options," Dr. Eugene Sun, vice president of global pharmaceutical clinical development at Abbott, said in a prepared statement. "The company is encouraged by committee member statements regarding the activity of Xinlay and the value of continuing development of the drug."

The FDA has requested additional trial data from the company, according to Abbott spokeswoman Jennifer Smoter.

Xinlay is currently in trials to determine if it can treat earlier-stage prostate cancer that doesn't respond to hormone therapy and hasn't spread. Abbott expects to end the study next year.

Abbott is also holding discussions with the FDA regarding proposed trials that would use Xinlay in combination with other cancer drugs, Smoter says.

Abbott shares fell 18 cents to $45.05.

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