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NCCN Updates Non-Hodgkin’s Lymphoma Guidelines

FORT WASHINGTON, Pa., April 22, 2008 — The National Comprehensive Cancer Network (NCCN) announces several new updates to the NCCN Clinical Practice Guidelines in Oncology™ Non-Hodgkin’s Lymphoma (NHL). These changes highlight leading developments in the treatment of NHL and represent the recognized standard for clinical care in oncology in both the community and the academic practice settings.

The NHL Guidelines now include bendamustine (Treanda®, Cephalon) as a treatment option for chronic lymphocytic leukemia (CLL). Specifically, bendamustine is included as a single agent for first-line therapy. For second-line therapy, it can be used as a single agent or in combination with rituximab (Rituxan®, Genentech).

Bendamustine was recently approved by the FDA for the treatment of patients with CLL based on the results of a pivotal phase III study, which showed that bendamustine was more effective than chlorambucil in patients with untreated CLL. Results of this international phase III study were presented at the 2007 American Society of Hematology Annual Meeting. At a median follow-up of 18.5 months, bendamustine produced a significantly higher overall response rate (68% vs. 39% for chlorambucil with a complete response of 30% vs. 2% for chlorambucil), median progression-free survival (21.7 months vs. 9.3 months with chlorambucil) and median duration of remission (18.9 months vs. 6.1 months with chlorambucil).

Bendamustine with or without rituximab is also included as an option for second-line therapy for patients with follicular lymphoma (FL) and mantle cell lymphoma (MCL) with a category 2B designation. This recommendation is based on the available data suggesting well-documented activity for bendamustine in patients with FL and MCL.