Cephalon to file cancer drug sooner than expected

ephalon Inc. said Thursday it plans to file a marketing application for its experimental cancer drug Treanda earlier than expected.

The biotechnology company said that based on data from a late-stage European study, it plans to file a U.S. marketing application for Treanda to treat chronic lymphocytic leukemia in the third quarter.

Previously, the company said it planned to file a marketing application for Treanda based on a trial in non-Hodgkin's lymphoma in the fourth quarter. The company said the filing for that indication is still on track.

Cephalon said the leukemia filing will be based on a clinical trial conducted in Europe that compared bendamustine, the active ingredient in Treanda, with the chemotherapy chlorambucil in patients with chronic lymphocytic leukemia who have not been previously treated.

The Phase III trial met its main goal and full data will be presented at a medical meeting in December.

Cephalon holds the rights to market and sell Treanda in the United States. Bendamustine is marketed in Germany by MundiPharma International under the name Ribomustin.

Cephalon will elaborate on its pipeline of experimental products at its research and development day for analysts beginning at noon.

source;www.signonsandiego.com