Pixuvri (Cell Therapeutics) approved in EU to treat adults with Non-Hodgkin B-Cell Lymphomas

The European Commission has given conditional marketing authorization for Pixuvri (pixantrone), from Cell Therapeutics, as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas. Approval is based on the PIX 301 Phase III trial which demonstrated that a greater proportion of patients achieved a complete response or unconfirmed complete response to Pixuvri than a comparator chemotherapy medicine, (20% versus 6%) and patients receiving Pixuvri survived for longer without their disease progressing (an average of 10.2 months versus 7.6 months). The most frequent side effect was suppression of the patient's bone marrow, resulting in low levels of white blood cells, platelets and red blood cells. Pixuvri will be marketed in the EU as Pixuvri 29 mg powder for concentrate for solution for infusion.