Pixantrone regulatory update

Cell Therapeutics said it will meet with FDA's Office of Oncology Drug Products early next month to discuss a resubmission of an NDA seeking accelerated approval of pixantrone to treat relapsed or refractory non-Hodgkin's lymphoma (NHL). Earlier this month, FDA concluded a review of the company's appeal of an April 2010 complete response letter for pixantrone, in which the agency requested an additional clinical trial. While FDA "denied the dispute appeal request to conclude that the efficacy of pixantrone has been demonstrated," the company said an additional trial would "not necessarily be required for accelerated approval." After the company appealed the letter, the agency asked for information to show that the decision to stop the Phase III PIX301 trial early was not based on an ongoing results assessment. FDA also requested an independent radiologic review to evaluate the primary endpoint of complete response rate compared to standard chemotherapy (see BioCentury, April 12, 2010; Dec. 13, 2010 & May 9, 2011). ...