Dr Lesley Russell, executive vice president of worldwide medical and regulatory operations, said: “This is our first regulatory filing for Treanda and a significant milestone for our growing oncology portfolio. We also are developing Treanda for the treatment of non-Hodgkin's lymphoma and are planning additional submissions for Cephalon oncology compounds to the FDA over the next 12 months.”
The NDA is based on a large, international multi-center Phase III 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, marketed as Leukeran by GlaxoSmithKline, is an FDA-approved first-line therapy for patients with CLL. In the pivotal trial, bendamustine HCl met both primary endpoints, overall response and progression-free survival and demonstrated an acceptable tolerability profile. The company anticipates that results from this study will be released at the upcoming American Society of Hematology annual meeting in December 2007.