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 are disappointed that brain metastases patients with limited options and serious neurologic problems will not have access to Xcytrin, which we believe has shown important clinical activity in this indication. We continue to believe that Xcytrin is a novel active cancer drug and we will seek a corporate partner to help support future development. In the meantime, we are also advancing our expanding and versatile pipeline of product candidates.”
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