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TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil
Date:12/10/2007

in the patients treated with bendamustine was 18.9 months compared to 6.1 months for those patients treated with chlorambucil. Bendamustine demonstrated a manageable tolerability profile. As would be expected of a chemotherapeutic agent the most common adverse events included myelosuppression, nausea, fatigue, diarrhea, vomiting and fever; the most common serious adverse events were febrile neutropenia and pneumonia.

"If approved, we believe TREANDA will be an important new treatment option for patients with CLL," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "Based on these study results and other data on bendamustine being presented at ASH, we envision TREANDA as the foundation of our growing oncology portfolio."

About the Phase 3 Study Design

The randomized, international, multicenter, open-label Phase 3 clinical trial evaluated the safety and efficacy of bendamustine compared to chlorambucil in previously untreated patients with B-CLL Binet stage B/C [equivalent to Rai stages I-IV], a measure of disease progression (n=305). Patients received bendamustine (100 mg per meters squared on days 1+2) (n=156) or chlorambucil (0.8 mg/kg on days 1+15) (n=149) for up to six treatment cycles. Safety and efficacy were assessed by an Independent Data Monitoring Committee.

About TREANDA (bendamustine HCl)

TREANDA is a novel chemotherapeutic agent, a hybrid of a purine analog and an alkylator. Preclinical data demonstrate that TREANDA acts in two distinct ways to kill cancer cells. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect of TREANDA may be attributable to its unique chemical design.

The FDA granted priority review to the new drug application (NDA) for TREANDA for the treatment
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SOURCE Cephalon, Inc.
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