The U.S. Food And Drug Administration approved today Treanda (bendamustine hydrochloride) as a drug for patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease.

Produced by Cephalon, 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."

Chronic lymphocytic leukemia (CLL) is one of four main types of leukemia. CLL starts with a change to a single cell called a lymphocyte. Over time, the CLL cells multiply and replace normal lymphocytes in the marrow and lymph nodes. The high number of CLL cells in the marrow may crowd out normal blood-forming cells, and CLL cells are not able to  fight infection like normal lymphocytes do.

CLL signs and symptoms usually develop slowly. Some CLL patients may have no signs or symptoms in the early stages of CLL and may have little or no change to their health for many years.

According to the American Cancer Society, 15,000 new cases of CLL will be diagnosed in the U.S. in 2008.

Cephalon has conducted a randomized, international, multicenter, open-label pivotal study of 301 treatment-naive patients with CLL. According to their findings those who received Treanda had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved chemotherapy for patients with CLL.

The side effects of Treanda are similar to those inducted by other chemotherapy drugs, including fewer white blood cells, nausea, anemia and vomiting.

Cephalon also submitted Treanda to FDA as a treatment for a different type of blood cancer, B-cell non-Hodgkin's lymphoma. The FDA’s decision is to be announced in October this year.