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CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
Date:7/21/2008

September meeting to focus on use of Zevalin as consolidation therapy after

remission induction in previously untreated patients with follicular

lymphoma

SEATTLE, July 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Company has scheduled a meeting with the U.S. Food and Drug Administration (FDA) in September to discuss the possibility of filing a supplemental Biologics License Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. The basis for the filing would be data from the First-line Indolent Trial that CTI recently gained access to through an agreement with Bayer Schering Pharma.

"We are pleased to have scheduled a meeting with the FDA to discuss a label expansion for Zevalin which could broaden its availability to patients," said James A. Bianco, M.D., President and CEO of Cell Therapeutics. "We continue to make progress with Zevalin on multiple fronts with clarity on reimbursement rates, deployment of our national sales team and now the opportunity to meet with the FDA to discuss possibly expanding the label for Zevalin."

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 non-Hodgkin's lymphoma who had achieved a partial response or a complete response 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 demonstrated that when used as a first-line consolidation therapy for patients with follicular non-Hodgkin's lymphoma, Zevalin significantly impro
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SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
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