Cephalon Inc., which said in October that it planned to file a new drug application for Treanda (bendamustine HCl) in non-Hodgkin's lymphoma before the end of 2007, met its goal with little room to spare, announcing the NDA on the last day of the year.

The news came only a month after the FDA accepted and granted a priority six-month review on the company's application for Treanda as first-line treatment of chronic lymphocytic leukemia (CLL) patients.

The new NDA seeks to market the drug in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab (sold as Rituxan by Genentech Inc. and Biogen Idec Inc.) or a rituximab-containing regimen.

Frazer, Pa.-based Cephalon is basing the submission on data from a pivotal, 100-patient study of Treanda in NHL. As reported in October, the single-arm study showed an overall response rate of 75 percent and a median duration of response of 40 weeks, or 9.2 months. (See BioWorld Today, Oct. 25, 2007.)

The National Cancer Institute estimated that in 2007, about 30,000 people were diagnosed with indolent NHL, a slow-growing cancer of the lymphatic system that has proved difficult to treat due to the high rate of relapse. Treanda, a chemotherapeutic agent, is a hybrid of a purine analogue and an alkylator and has shown, in preclinical studies, an ability to kill cancer cells by damaging cancer cell DNA, which promotes both apoptosis and disruption of cell division.

Cephalon gained rights to Treanda through its 2005 acquisition of San Diego-based Salmedix Inc., which previously licensed the compound from Fujisawa Deutschland GmbH, of Munich, Germany.

Bendamustine HCl currently is marketed in Germany under the trade name Ribomustin as a single agent or in combination with other cancer agents for indolent NHL, multiple myeloma and CLL.

Shares of Cephalon (NASDAQ:CEPH) closed at $71.76 Monday, down 64 cents.