TREANDA New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Sta... (TREANDA is marketed in Germany by Astell...)

TREANDA New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA

Date:12/3/2007

TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asian countries.

TREANDA in CLL

The TREANDA NDA for the treatment of patients with CLL is based on a large, international multi-center Phase 3 clinical trial that evaluated the safety and efficacy of bendamustine HCl, the active ingredient in TREANDA, compared to chlorambucil in patients who were not previously treated for their disease. Chlorambucil, a chemotherapy drug, is FDA-approved as a first-line therapy for patients with CLL. In the pivotal trial, bendamustine HCl met both primary endpoints -- overall response rate and progression-free survival -- and demonstrated a manageable tolerability profile. The company anticipates that results from this study will be released at the American Society of Hematology (ASH) annual meeting, which begins on December 8, 2007 in Atlanta, Georgia.

TREANDA in NHL

The company has also studied TREANDA for the treatment of patients with indolent non-Hodgkin's lymphoma (NHL) whose cancer is no longer responsive to treatment with rituximab. This study also met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile. The company anticipates filing an NDA in the fourth quarter of 2007 for TREANDA in patients with indolent NHL who failed treatment with rituximab. In addition, Cephalon has studied TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. Results from these studies of TREANDA as monotherapy and in combination will be presented at medical meetings later this year.

About Cephalon Oncology
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