"We believe that gaining access to these important Zevalin trial data and regulatory documents will allow for the potential to expand the label in the U.S. to include consolidation of first-line therapy, as Bayer Schering Pharma did in Europe, and may give more patients access to the potential benefits of Zevalin," said James A. Bianco, M.D., President and CEO of Cell Therapeutics. "We are pleased with Bayer's willingness to support our efforts to potentially broaden U.S. patient access to this important therapeutic, and delighted to be working with such a talented group of dedicated healthcare professionals."
Cell Therapeutics has requested a meeting with the Food and Drug Administration (FDA) to discuss expanding the label for Zevalin in the U.S. to include consolidation following first-line treatment of follicular lymphoma based on the FIT trial data. If approved, this new indication has the potential to increase the market for Zevalin in the U.S.
About the Phase III First-line Indolent (FIT) Trial
The multinational, randomized phase III First-line Indolent Trial (FIT)
evaluated the benefit and safety of a single infusion of Zevalin in
patients with CD20-positive follicular lymphoma who had achieved a partial
remission or a complete remission after receiving standard first-line
chemotherapy regimens. The FIT trial results were presented in one oral and
two poster presentations at the American Society of Hematology (ASH)
conference in December 2007. The FIT trial demons
|SOURCE Cell Therapeutics, Inc.|
Copyright©2008 PR Newswire.
All rights reserved