Pixuvri pixantrone regulatory update

Cell Therapeutics appealed an April complete response letter for an NDA for Pixuvri pixantrone to treat relapsed or refractory non-Hodgkin's lymphoma (NHL). The company expects a response from FDA on the appeal next quarter. Prior to receiving the April letter, in which FDA requested an additional clinical trial of Pixuvri, an advisory panel unanimously voted against approval of the aza-anthracenedione DNA intercalating agent that inhibits topoisomerase II (TOP2) (see BioCentury, April 12). ...