Cephalon Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA® (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease.
The American Cancer Society estimates that more than 15,000 new cases of this rare disease will be diagnosed in the United States this year. The TREANDA application as a CLL treatment received priority review from the FDA and was approved within six months of the September 2007 submission. Cephalon anticipates that TREANDA will be available to physicians and patients as a CLL treatment in the United States in April 2008.
"TREANDA is an important new treatment for patients with chronic lymphocytic leukemia, and this first-cycle approval by FDA represents a significant milestone in the growth of our oncology business," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "With a strong pipeline of near- and longer-term opportunities, Cephalon Oncology is poised to deliver therapies that target both hematologic cancers and solid tumors for patients in need of new options."
Dr. Bruce Cheson, Professor of Medicine at Georgetown University Hospital, Washington, D.C., stated, "Patients with chronic lymphocytic leukemia can often live normal lives for many years because of treatments that control the disease over the long-term. TREANDA is an effective new option that offers a delay in disease progression, an important goal for patients with chronic lymphocytic leukemia."