FDA to decide on pixantrone in April

Seattle-based pharmaceutical company Cell Therapeutics (CTI) announced Tuesday that the US Food & Drug Administration will make a final decision on whether or not to give market approval to CTI's oncology product pixantrone (Pixurvi) by April 24, 2012.

Last year the FDA chose to reject pixantrone after an oncology panel unanimously recommended that the FDA do just that. The rejection came on the heels of a poorly executed pivotal Phase III trial of the drug and the unconvincing data. Instead of completing a new trial, CTI appealed the FDA's decision. And it is this appeal that the FDA will be answering in April.

CTI will learn whether pixantrone receives market approval in Europe next month.

CTI has pushed pixantrone first as a third-line therapy for non-Hodgkin's lymphoma patients who have failed two prior therapies, then as a second-to-fourth line therapy for the same indication.

Source: Boston Globe

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