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FDA grants priority review for Zevalin

This article was originally published in Scrip

Executive Summary

The US FDAhas granted priority review for the sBLA for use ofCell Therapeutics' radioimmunotherapy Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma (NHL) 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, shortening the timeframe for FDA review from 10 months to six months. The PDUFA target date is April 2nd, 2009. If the sBLA is approved, Cell Therapeutics estimates that there would be approximately 18,000 additional patients who would potentially be eligible to use Zevalin under the proposed expanded label. The company filed the sBLA in October on the basis of the Phase III FIT trial, where the radioimmunotherapy extended median progression-free survival from 13.5 months to 37 months (ScripOnline, October 3rd, 2008). Zevalin is currently approved in the US for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients refractory to Roche/Genentech/Biogen Idec's blockbuster NHL drug Rituxan (rituximab).






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