Cell Therapeutics Completes NDA Submission For Pixantrone

Cell Therapeutics (CTI) has completed the submission of New Drug Application (NDA) to the FDA for pixantrone. It is intended to treat relapsed or refractory, aggressive non-Hodgkin’ lymphoma (NHL).

CTI has also requested priority review, which if granted, could lead to an approval decision from FDA in the fourth quarter of 2009.

NDA application is based on the PIX 301 EXTEND trial. The trial was a phase-III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL, who received two or more prior therapies and who were sensitive to treatment with anthracyclines.

The trial patients were randomized to receive either pixantrone or another single-agent drug, currently used for the treatment of this patient population as selected by the physician.

James Bianco, CEO of CTI, said: This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business. This represents a significant advance in the treatment of patients with relapsed/refractory aggressive NHL, a patient population which the FDA has acknowledged represents an unmet medical need.