Cancer Drug Not Approvable, U.S. FDA Says

Pharmacyclics, Inc. announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for the company’s new drug application (NDA) for Xcytrin (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases. The NDA for use of Xcytrin in combination with whole brain radiation therapy (WBRT) was filed with the FDA in April 2007.
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