Cephalon, Inc. said the US Food and Drug Administration (FDA) has granted priority review status to its Treanda (bendamustine HCl) New Drug Application (NDA) for the first-line treatment of patients with chronic lymphocytic leukaemia (CLL).
CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States. Cephalon filed the Treanda NDA for CLL in September 2007 and the FDA will make a review decision by the end of March 2008.
"If approved, Treanda will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be available as soon as the second quarter of 2008," said Dr. Lesley Russell, executive vice president, Worldwide Medical and Regulatory Operations.
The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where no adequate therapy exists. Priority review reduces the targeted NDA review time from 10 months to six months. FDA granted orphan drug status for Treanda for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the United States, if the product is approved for this indication.
Treanda is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that this rationally designed hybrid acts in two ways to kill cancer cells. Treanda damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis). It also stops cancer cells from dividing to create new cancer cells. This dual-action of Treanda may be attributable to its unique chemical design.
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 Asian countries.
The Treanda NDA for the treatment of patients with CLL is based on a large, international multi-centre 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, 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 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, the company said.
Cephalon Oncology is a strategic business unit focused on the development and commercialisation of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio in the United States includes Trisenox (arsenic trioxide) Injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukaemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase III development for acute myeloid leukaemia.
Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World Economic Forum Community of Global Growth Companies. For 20 years, the company has been dedicated to the discovery, development and commercialisation of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction.