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Expanded Label for Ibritumomab Tiuxetan Gets Priority Review

Expanded Label for Ibritumomab Tiuxetan Gets Priority Review

Cell Therapeutics, Inc, recently announced that the US Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of 90Y-ibritumomab tiuxetan (Zevalin) as consolidation therapy for patients with follicular B-cell non-Hodgkin lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009, has been established by the FDA for a decision regarding the approval of the sBLA. If approved, ibritumomab tiuxetan would be the first radioimmunotherapy available to patients as first-line consolidation therapy. It is estimated that there would be approximately 18,000 additional patients that currently receive first-line treatment which would potentially be eligible to use the agent under the proposed expanded label

 
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