Cell Therapeutics, Inc. (CTIC) Files Appeal on FDA Decision for Pixantrone
Cell Therapeutics, Inc. (“CTI”) has filed a formal appeal with the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research to contest the decision from earlier this year on CTI’s New Drug Application (“NDA”) for pixantrone as a therapy for relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its pixantrone NDA for a patient group as there are no drugs currently approved in this clinical setting. A portion of the Office of Oncology Drug Products’ requested Complete Response Letter stated that CTI's prior clinical trial, PIX301, did not demonstrate…