Pixantrone* is a novel aza-anthracenedione derivative with unique structural and physio-chemical properties. Unlike related compounds, pixantrone forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixantrone was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite - both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow pixantrone to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.
The pivotal Phase 3 EXTEND, or PIX301, randomized clinical trial evaluated pixantrone for patients with relapsed or refractory aggressive NHL. The EXTEND study was published in Lancet Oncology in May 2012. PIXUVRI® (pixantrone) was granted conditional marketing authorization by the European Commission (EC) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL in May 2012. There are no drugs approved for this indication in the United States.
An ongoing randomized, controlled Phase 3 clinical trial, known as PIX-R or PIX306, currently is enrolling patients.Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant Now enrolling.
*Pixantrone (PIXUVRI) was granted conditional marketing approval in the E.U. in May 2012 as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphomas. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.