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FDA Meeting Provides Green Light for Cell Therapeutics Submission of Supplemental Filing for Zevalin(R) Label Expansion
Date:9/21/2008

Supplemental Biologics License Application (sBLA) on track for Q4

Submission

SEATTLE, Sept. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD and MTA: CTIC) announced today that following a meeting with the U.S. Food and Drug Administration (FDA) data from the First-line Indolent Trial (FIT) would be sufficient to support a submission for a supplemental Biologics License Application (sBLA). The sBLA will propose a label expansion to include use of the Zevalin(R) therapeutic regimen ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. The Company plans to submit the sBLA in the fourth quarter and request priority review, which if granted, would result in a six month review period. CTI gained access to the FIT data through an agreement with Bayer Schering Pharma who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe.

"We are pleased with the collegial interaction with the FDA and their guidance on our plan for submitting the FIT trial results to expand the Zevalin label," said James A. Bianco, M.D., CEO of Cell Therapeutics. "Label expansion for first-line indication would make this important treatment option available to the tens of thousands of patients who may benefit."

Zevalin is currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-g
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