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Pharmacyclics: FDA Will Not Accept Drug Marketing Application for Cancer Drug
Posted on 2007-02-21 10:31:00
SUNNYVALE, Calif. (AP) -- Shares of Pharmacyclics Inc. sunk to a 52-week low Wednesday after announcing that the Food and Drug Administration will not accept a marketing application for the company's drug to treat lung cancer that has spread to the brain.
The company received a "refuse to file" letter stating that a marketing application for Xcytrin—its lead candidate—was not complete enough to allow for an FDA review. The agency said it was unable to review the clinical studies, which failed to show that Xcytrin worked significantly better than a placebo given the application.
Pharmacyclics said it was evaluating whether to pursue the specific indication for the drug, adding that it was evaluating the drug for other cancers.
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