European committee recommends pixantrone be granted conditional approval

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Claiming the medication satisfies an unmet medical need, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Cell Therapeutics' (CTI) oncology product Pixuvri (pixantrone) be granted conditional approval for the treatment of B-cell non-Hodgkin’s lymphoma in patients with aggressive disease that has relapsed or recurred after "multiple rounds of previous chemotherapy or is not responding to other treatments."

Conditional approval was granted, and not full approval, as the committee believed the data supplied by CTI displays a medical benefit that outweigh the risks but is not yet comprehensive, and that more information will be required on the benefits.

This is a surprising accomplishment for CTI in Europe, but it will not sway the US FDA's negative opinion on pixantrone and the data supporting it.

Source: EMA

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