Cell Therapeutics, Inc. (CTI) announced that the U.S. 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 Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's 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 Zevalin sBLA. If approved, Zevalin 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 Zevalin under the proposed expanded label.
CTI and Spectrum Pharmaceuticals, Inc. entered into an agreement to form a 50/50 owned joint venture, RIT Oncology LLC, on November 26, 2008 to commercialize and develop ZEVALIN in the United States and expects the transaction will close in early December, 2008. CTI initially acquired the US rights to Zevalin from Biogen Idec in December 2007. CTI gained access to the First-line Indolent Trial (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.
"We are pleased that the FDA, by granting the application priority review status, acknowledges that the use of Zevalin in the first-line consolidation setting could represent an important treatment option for follicular B-cell non-Hodgkin's lymphoma patients," said James A. Bianco, M.D., CEO of Cell Therapeutics. "In addition to shortening the timeframe for FDA review from 10 months to 6 months, it would also enable physicians to get this drug to those who may benefit from it sooner. If approved, it also pushes up our anticipated timeline for commercial launch for first-line indication by 4 months which should result in a substantial increase to our revenue forecast in 2009."
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.