FDA Sets date for Pixantrone Decision

7 September 2009 (Last Updated September 7th, 2009 18:30)

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 ant

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.