Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced the launch of PIXUVRI® (pixantrone), the first new treatment for adult patients in the United Kingdom (UK) with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL), at the 54th annual scientific meeting of the British Society for Haematology.
PIXUVRI is the first monotherapy treatment option for this patient group and the only therapy licensed for third and fourth line use in aggressive B-cell NHL patients, which includes diffuse large B-cell lymphoma (DLBCL). There are approximately 37,000 new cases of aggressive B-cell NHL every year in the European Union (EU), and CTI estimates that up to 1,600 to 1,800 people in the UK are diagnosed with aggressive B-cell NHL each year. Patients with aggressive B-cell NHL who relapse after second-line treatment have a poor survival prognosis ranging from only several weeks to 12 months.
Professor Finbarr E. Cotter, Professor of Haematology and Chair of Experimental Haematology, Centre for Haemato-Oncology, Barts Cancer Institute, and representative for the British Society for Haematology (BSH) said, "The availability of PIXUVRI in the UK is an important milestone for patients who have aggressive B-cell NHL. DLBCL is the most common type of aggressive NHL and despite undoubted progress in the last 10 years resulting from the introduction of better first-line therapy, the disease still recurs in some patients. A new therapy that delivers effective treatment with manageable side effects offers real hope for these patients that fail second- or third-line therapy."
PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. The PIX301 phase 3 clinical trial demonstrated anti-lymphoma activity of PIXUVRI and a predictable and manageable side effect profile compared to other treatments for this condition.
James A. Bianco, M.D., President and Chief Executive Officer of CTI, said, "At CTI, we prioritise the patient experience and are committed to developing therapeutic options for people living with cancer who want a chance at a longer and better quality of life. We are pleased to be able to bring PIXUVRI to patients in the UK, addressing a critical gap in care for patients at this stage of the disease living with few, if any effective treatment options."
The launch in the UK of PIXUVRI follows conditional marketing authorization by the European Commission (EC) in 2012 and the National Institute for Health and Care Excellence final guidance recommending prescription of PIXUVRI as a cost-effective monotherapy in early 2014. PIXUVRI is currently available in Austria, Denmark, Finland, Germany, Italy, France, Netherlands, Norway, Sweden and the UK. CTI intends to pursue making PIXUVRI available in other European countries in 2014.