FDA approves TREANDA (bendamustine hydrochloride) for chronic lymphocytic leukemia

Cephalon, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease, on March 20, 2008.

The American Cancer Society estimates that more than 15,000 new cases of this rare disease will be diagnosed in the United States this year. The TREANDA application as a CLL treatment received priority review from the FDA and was approved within six months of the September 2007 submission. Cephalon anticipates that TREANDA will be available to physicians and patients as a CLL treatment in the United States in April 2008.

"TREANDA is an important new treatment for patients with chronic lymphocytic leukemia, and this first-cycle approval by FDA represents a significant milestone in the growth of our oncology business," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "With a strong pipeline of near- and longer-term opportunities, Cephalon Oncology is poised to deliver therapies that target both hematologic cancers and solid tumors for patients in need of new options."

Dr. Bruce Cheson, Professor of Medicine at Georgetown University Hospital, Washington, D.C., stated, "Patients with chronic lymphocytic leukemia can often live normal lives for many years because of treatments that control the disease over the long-term. TREANDA is an effective new option that offers a delay in disease progression, an important goal for patients with chronic lymphocytic leukemia."

In a randomized, international, multicenter, open-label pivotal study of 301 treatment-naïve patients with CLL, those who received TREANDA had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved chemotherapy for patients with CLL. Specifically, TREANDA patients had a significantly higher overall response (59 percent of patients responded to TREANDA and 26 percent of patients responded to chlorambucil; p < 0.0001). Patients who received TREANDA also had a higher complete response rate than those treated with chlorambucil (8 percent vs. < 1 percent), which means that after treatment with TREANDA, some patients had no signs of disease in their blood.

Importantly, TREANDA patients also had a significantly longer progression-free survival (18 months vs. 6 months; Hazard Ratio = 0.27; p < 0.0001), meaning the disease did not get worse for a significant period of time. The response to TREANDA lasted longer (duration of response) than in patients who received chlorambucil (19 months vs. 7 months). The most common adverse events in the trial were myelosuppression, fever, nausea, and vomiting.

TREANDA has been granted orphan drug status by the FDA for the treatment of CLL. The orphan drug designation will provide marketing exclusivity in this indication until March 2015.

TREANDA has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that TREANDA can lead to cell death via several pathways. 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 (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of TREANDA remains unknown.

In December 2007, Cephalon submitted an NDA requesting approval of TREANDA for the treatment of patients with indolent (slow-growing) non-Hodgkin's lymphoma who have progressed during or following treatment with rituximab or a rituximab-containing regimen and anticipates a review decision by October 31, 2008. The protocol for the TREANDA NHL pivotal trial received special protocol assessment (SPA) approval from the FDA in February 2006. The SPA process allows for FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and/or data analysis.

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN®. 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 Asia Pacific Rim countries.

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