Cephalon, Inc. said the US Food and Drug Administration (FDA) has accepted the company's new drug application (NDA) for Treanda (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen.
According to the National Cancer Institute, an estimated 30,000 people in the United States were expected to be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment. Cephalon submitted the Treanda application for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 31, 2008.
"We are pleased that the application for Treanda to treat relapsed indolent NHL is on track. With two NDAs for Treanda pending review decisions, 2008 is a significant year for this product and bodes well for the future of Cephalon in oncology," said Dr. Lesley Russell, executive vice president, Worldwide Medical and Regulatory Operations.
The Treanda NDA for relapsed indolent NHL is supported by three studies in patients with NHL, including two single-agent studies and one in combination with rituximab. In these studies, patients treated with Treanda had a high rate of response and a manageable and tolerable side effect profile, with adverse events similar to those observed with other chemotherapy agents such as myelosuppression (decrease in blood counts), nausea, and vomiting.
Treanda is a hybrid of a purine analog and an alkylator making it a novel chemotherapeutic agent. 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 (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The precise mechanism of action of Treanda in humans has not been fully characterised.
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. In 2007, Cephalon filed a request for orphan drug status for TREANDA as a treatment for patients with relapsed indolent NHL and the company is in discussion with FDA about this application.
In September 2007, Cephalon submitted an NDA requesting approval of Treanda for the treatment of patients with chronic lymphocytic leukaemia (CLL), for which the FDA has granted priority review and orphan drug status; a decision by the FDA is expected by March 20, 2008.
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.