Cephalon Announces Plans for NDA Filing for Treanda

Based on data from a European study, Cephalon announced that it plans to file a new drug application (NDA) with the FDA for Treanda for the treatment of chronic lymphocytic leukemia (CLL).

The multicenter Phase III clinical trial evaluated the safety and efficacy of bendamustine, the active ingredient in Treanda (bendamustine HCl), compared with chlorambucil in patients with treatment-naive B-CLL.

According to the company, the data from this trial met its primary endpoint of overall response rate and will be the basis for the company’s NDA filing.