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news.Cell Therapeutics, a biopharmaceutical company, has announced that the FDA has accepted for filing and review, and has granted priority review status for, the supplemental biologics license application for use of Zevalin as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy.
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Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. A Prescription Drug User Fee Act target date of April 2, 2009 has been established by the FDA for a decision regarding the approval of the Zevalin supplemental biologics license application (sBLA). If approved, Zevalin would be the first radioimmunotherapy available to patients as first-line consolidation therapy, the company said.
Previously, CTI and Spectrum Pharmaceuticals entered into an agreement to form a 50/50 owned joint venture, RIT Oncology, to commercialize and develop Zevalin in the US. The transaction is expected to close in early December, 2008.
James Bianco, CEO of Cell Therapeutics, said: 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.
In addition to shortening the time-frame for the FDA review from 10 months to six 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 four months which should result in a substantial increase to our revenue forecast in 2009.