FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma

Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug application (NDA) for TREANDA(R) (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen. According to the National Cancer Institute, an estimated 30,000 people in the United States were expected to be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment. Cephalon submitted the TREANDA application for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 31, 2008.