Lung Cancer
Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
Published in Food and Drug Law Weekly, January 11th, 2008
Pharmacyclics, Inc. (NASDAQ:PCYC) 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(R) (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.
According to the National Cancer Institute, over 200,000 patients will be diagnosed with lung cancer this year in the U.S. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50% of lung cancer...
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