Approval would make Zevalin only Radioimmunotherapy in U.S. to be Indicated
for Use in First-Line Therapy
SEATTLE, Oct. 2 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. If approved, Zevalin would be the only radioimmunotherapy in the U.S. with approval for use as first-line consolidation therapy. The Company has requested 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 AG, Germany who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe.
"If the sBLA is approved there would be approximately 18,000 additional patients that currently receive first-line treatment that would potentially be eligible to use Zevalin under the proposed expanded label," said James A. Bianco, M.D., CEO of Cell Therapeutics. "The submission is a major milestone for CTI as approval could have an important impact on the treatment of follicular non-Hodgkin's lymphoma and we would expect it to significantly enhance the value of the product for CTI and our shareholders."
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-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.
|SOURCE Cell Therapeutics, Inc.|
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