Pixuvri pixantrone regulatory update

Cell Therapeutics withdrew an NDA for Pixuvri pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed >=2 lines of prior therapy. Cell Therapeutics made the move after FDA did not grant the company's request to reschedule the Feb. 9 Oncologic Drugs Advisory Committee (ODAC) meeting on the NDA for late March. Cell Therapeutics said it needed additional time to prepare for the meeting. The PDUFA date was April 24. The company plans to resubmit the NDA later this year. The biotech was seeking accelerated approval based on the Phase III PIX301 trial, in which pixantrone met the primary endpoint of a higher complete response rate than standard chemotherapy (see BioCentury, Dec. 20, 2010 & Jan. 9, 2012). ...