The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for pixantrone, a new treatment for non-Hodgkin's lymphoma from Cell Therapeutics.
Pixantrone is a new treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL), with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents.
Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukaemia and breast cancers but over an extended period they can cause cumulative heart damage. As a result, there is a lifetime limit of anthracycline doses, and patients with recurring cancer can often not return to the same therapy.
Cell Therapeutics chief executive officer James Bianco said that the company looked forward to the final decision on the request for priority review.
"The FDA's acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL," Bianco said.
A Prescription Drug User Fee Act date will be established by the FDA regarding the review of the pixantrone NDA by 4 September 2009.