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Title: Bendamustine Added to US Treatment Guidelines for Leukaemia, Lymphomas

"Bendamustine Added to US Treatment Guidelines for Leukaemia, Lymphomas"

FORT WASHINGTON, Pa -- April 24, 2008 -- The US National Comprehensive Cancer Network (NCCN) announced 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 recognised standard for clinical care in oncology in both the community and the academic practice settings. The NHL Guidelines now include bendamustine (Treanda) as a treatment option for chronic lymphocytic leukaemia (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). Bendamustine was recently approved by the US Food and Drug Administration for the treatment of patients with CLL based on the results of a pivotal phase 3 study, which showed that bendamustine was more effective than chlorambucil in patients with untreated CLL. Results of this international phase 3 study were presented at the Annual Meeting of the American Society of Hematology in 2007. At a median follow-up of 18.5 months, bendamustine, in comparison with chlorambucil, produced a significantly higher overall response rate (68% vs 39%), complete response rate (30% vs 2%), longer median progression-free survival (21.7 vs 9.3 mo), and longer median duration of remission (18.9 vs 6.1 mo). Bendamustine with or without rituximab is also included as an option for second-line therapy in 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. The updated NCCN guidelines are available online at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf. SOURCE: National Comprehensive Cancer Network (NCCN)

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