Cell Therapeutics, Inc (CTI) has completed the submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTI requested priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is currently available in Europe on a named-patient basis.
"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," said James A Bianco, chief executive officer of CTI. "With more than 76,000 pages and 500,000 hyperlinks this submission represents the hard work of many CTI employees dedicated to making a difference in the lives of patients with cancer. This also 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."
Pixantrone (BBR 2778), is a novel major groove binder with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.