FDA News

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin

(July 22, 2008)-- Cell Therapeutics has announced 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-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."

For additional information, please visit http://www.celltherapeutics.com.

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