ARTICLE | Clinical News

Pixantrone regulatory update

March 8, 2010 8:00 AM UTC

FDA rescheduled an Oncologic Drugs Advisory Committee meeting for March 22 to discuss NDAs for Pixuvri pixantrone from Cell Therapeutics and Omapro omacetaxine from ChemGenex Pharmaceuticals. FDA had postponed the meeting, which was originally planned for Feb. 10, because of weather conditions in Washington. Pixuvri is under review to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) with an April 23 PDUFA date. In briefing documents posted last month, FDA reviewers indicated Cell Therapeutics had not met the statistical hurdle in its trial of the aza-anthracenedione DNA intercalating agent that inhibits topoisomerase II (TOP2). ...