Cell Thera submits pixantrone rolling NDA

Seattle, USA-based Cell Therapeutics has submitted a rolling New Drug Application to the Food and Drug Administration for pixantrone in the  treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma.

The firm's pivotal Phase III EXTEND trial achieved its primary endpoint  with patients randomized to treatment with pixantrone showing a  significantly-higher rate of confirmed and unconfirmed complete  remissions compared to those treated with standard chemotherapy with no  subjects in the standard chemotherapy arm achieving a confirmed complete  remission.

"The commercialization of pixantrone will drive shareholder value as a  result of the large market potential for this product," said chief  executive James Bianco. "We believe that the recent significant  investment in Cell Thera by a single institutional investor reflects a  growing interest in Cell Thera and, in particular, in pixantrone by the  investment community," he added.