Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin'... ( TREANDA Receives Second Indicatio...)

Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

Date:10/31/2008

TREANDA Receives Second Indication this Year; Data Demonstrate High, Durable Response Rates for Patients with indolent NHL Who Have Progressed

Following a Rituximab-Containing Regimen

FRAZER, Pa., Oct. 31 /PRNewswire-FirstCall/ -- Cephalon, Inc., (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA(R) (bendamustine hydrochloride) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The data supporting the FDA approval show that TREANDA is effective, has a tolerable side effect profile in patients with indolent NHL and that treatment results in a high durable response rate. In March of this year, TREANDA received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the United States.

Indolent NHL, a subset of non-Hodgkin's lymphoma, is a slow growing but serious cancer of the lymphatic system that is not curable with currently available treatments. Patients with indolent NHL are prone to multiple relapses after initial therapy. According to the National Cancer Institute, an estimated 30,000 people in the United States will be diagnosed this year with indolent NHL.

"Because most patients with indolent non-Hodgkin's lymphoma eventually become resistant to existing treatments, new treatment options like TREANDA are needed to improve patient outcome," stated Dr. Bruce Cheson, Professor of Medicine at Georgetown University Hospital, Washington, D.C. and TREANDA clinical investigator. "The TREANDA pivotal trial shows that it is an effective and well-tolerated chemotherapy that offers a delay in disease progression for more than nine months."

According to Dr. Lesley Russell, Executive Vice President and Chief Medical Officer, Cephalon, "We are excited about this seco
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