Pixuvri pixantrone regulatory update

The European Commission granted conditional approval to an MAA from Cell Therapeutics for Pixuvri pixantrone to treat patients with multiply relapsed or refractory aggressive non-Hodgkin's B cell lymphoma. The company plans to initially make the product available through a named patient program in the EU, with an official launch next half. The MAA is based on the Phase III PIX301 trial, which showed that Pixuvri met the primary endpoint of complete response rate compared with standard chemotherapy (20% vs. 6%, p=0.02) (see BioCentury, Nov. 17, 2008). As part of the approval, Cell Therapeutics is required to submit data from the ongoing Phase III PIX306 trial by June 2015 to confirm Pixuvri's clinical benefit. The product is an aza-anthracenedione DNA intercalating agent that inhibits topoisomerase II (TOP2). ...