The US Food and Drug Administration (FDA) has set 23 April 2010 as the final date for approval of Cell Therapeutics’ pixantrone, a potential treatment for relapsed or refractory aggressive non-Hodgkin’s lymphoma.
Pixantrone is a novel topoisomerase II inhibitor that does not rely on anthracyclines, which are generally used as a first-line treatment for lymphoma, leukaemia and breast cancer even though they can result in cumulative heart damage over time.
As a result, there is a limit on anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further treatment if their disease returns.
CTI executive officer James A Bianco said that the 18-month follow-up PIX 301 pivotal trial data continues to demonstrate further improvement in primary and secondary endpoints for pixantrone.
“We look forward to providing the four-month safety and efficacy update to the FDA and working with them toward potential approval,” said Bianco.
Cell Therapeutics believes that if fast-track approval is granted pixantrone could be available to patients in the US early in the second quarter of 2010.