Pharmacyclics, Inc (PCYC) Receives Non-Approvable Letter from the FDA
Pharmacyclics, Inc. (PCYC) announced that the company has received a non-approvable letter from the U.S. Food and Drug Administration regarding the company's new drug application for Xcytrin Injection. This drug, used in combination with whole brain radiation therapy, would seek to treat non-small cell lung cancer in brain metastases. 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 patients. Richard A. Miller, president and CEO, stated "We…