Pixuvri pixantrone regulatory update

The European Medicines Agency (EMA) accepted for review an MAA from Cell Therapeutics for Pixuvri pixantrone to treat adult patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). The company also agreed to withdraw Orphan Drug designation for the compound due to the expansion of the MAA to a broader population than the designated indication of diffuse large B cell lymphoma (DLBCL).

In April, FDA issued a complete response letter for an NDA for the aza-anthracenedione DNA intercalating agent that inhibits topoisomerase II (TOP2) to treat relapsed or refractory aggressive NHL (see BioCentury, April 12). ...