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Bendamustine NDA Submitted for Review

FRAZER, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (NASDAQ:CEPH) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of TREANDA(R) (bendamustine HCl) for the treatment of patients with chronic lymphocytic leukemia (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, according to the National Cancer Institute. If approved, TREANDA would be the first new therapy approved by the FDA for the treatment of CLL since 2001. In August 2007, the FDA granted orphan drug designation to TREANDA for this indication.

"This is our first regulatory filing for TREANDA and a significant milestone for our growing oncology portfolio," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "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 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 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 (ASH) annual meeting in December 2007.

The company also is studying TREANDA for the treatment of patients with indolent (or slowly-progressing) non-Hodgkin's lymphoma (NHL), who are refractory to the monoclonal antibody rituximab. Pending positive results from this ongoing study, the company anticipates filing an NDA for TREANDA in patients with indolent NHL who are refractory to rituximab in the fourth quarter of 2007. In addition, Cephalon is studying TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. The company anticipates that results from studies of TREANDA as monotherapy and in combination will be presented at medical meetings later this year.

Upon FDA acceptance of the company's NDA filing of TREANDA for CLL, the company will make a $15 million milestone payment to former shareholders of Salmedix.

About TREANDA
TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that TREANDA induces rapid, sustained single- and double-strand DNA damage, which results in apoptosis, or programmed cell death, in the tumor. TREANDA also induces mitotic checkpoint inhibition, which results in non-apoptotic cell death. TREANDA causes DNA disruption that is both extensive and durable exhibiting a low level of cross-resistance to other cytotoxic agents. The dual-effect of the anti-tumor activity 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 Deutschland GmbH. Bendamustine HCl, the active ingredient in 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 market and sell bendamustine HCl in Asia.

Source: Cephalon

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