Cell Therapeutics initiates rolling NDA submission for lymphoma drug

Cell Therapeutics (CTI) expects to complete the submission this quarter and will request priority review which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009.

The pixantrone study received special protocol assessment approval from the FDA in 2004, and pixantrone has received fast track designation for this indication. The FDA’s fast track programs are intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

The rolling submission process enables companies that have been granted fast track designation to submit sections of the new drug application (NDA) to the FDA as they become available, allowing the review process to begin before the complete dossier has been submitted.

James Bianco, CEO of CTI, said: “This is a significant milestone for CTI as we move pixantrone closer to addressing a truly significant unmet medical need for relapsed or refractory aggressive non-Hodgkin’s lymphoma patients. The commercialization of pixantrone will drive shareholder value as a result of the large market potential for this product.

“We believe that the recent significant investment in CTI by a single institutional investor reflects a growing interest in CTI and in particular in pixantrone by the investment community. With added financial resources, CTI can advance pixantrone through the NDA review process while we continue our progress on strategic business development opportunities and relationships.”