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Pharmacyclics cancer drug not approvable--US FDA


Posted on: 01/05/2008

Pharmacyclics cancer drug not approvable--US FDA

Fri Dec 21, 2007 7:17pm EST

LOS ANGELES, Dec 21 (Reuters) - Drug developer Pharmacyclics Inc (PCYC.O:) said on Friday that the U.S. Food and Drug Administration turned down its application to market Xcytrin as a treatment for non-small cell lung cancer which has spread to the brain.

The company said in a statement that it continues to believe that Xcytrin is a novel active cancer drug and will seek a corporate partner to help support future development.

Pharmacyclics said it expects data in the first half of 2008 from three Phase 2 trials evaluating the drug in patients with advanced relapsed non-small cell lung cancer.

The company had been seeking approval for use of Xcytrin in combination with whole brain radiation therapy. (Reporting by Deena Beasley in Los Angeles; Editing by Gary Hill)


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