RxTrials Institute Drug Pipeline Alert

Cephalon has received FDA approval for Treanda as a treatment for patients with chronic lymphocytic leukemia.

The Treanda (bendamustine hydrochloride) application was submitted last September and received priority review. The NDA was based on an international multicenter Phase III trial that evaluated the safety and efficacy of bendamustine HCl, the drug’s active ingredient, versus chlorambucil in previously untreated patients. The trial met both primary endpoints — overall response and progression-free survival, Cephalon said.

The FDA granted the drug orphan status for this indication, giving the company marketing exclusivity until March 2015.