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March 1, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the private German Institute for Quality and Efficiency in Health Care (IQWiG) has published its report on the preliminary benefit assessment of PIXUVRI
® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL). In
May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI in the European Union (E.U.) for this indication based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial. In its evaluation of the manufacturer submission, IQWiG concluded that no additional benefit could be determined for PIXUVRI because there is no standard of care with limited comparator data within the guidelines IQWiG follows. The Federal Joint Committee (G-BA) is the ultimate authority in determining reimbursement for drugs in
Germany. Public comment on IQWiG's assessment report can be submitted to the G-BA until
March 22, 2013. The G-BA is scheduled to hold a public hearing on
April 8 or 9, 2013 and then decide on the innovation score and the additional benefit vs. the self-assigned comparator therapies in the second quarter of 2013. IQWiG's current assessment has no immediate impact on the reimbursement of PIXUVRI or physician's ability to prescribe this new treatment in
"PIXUVRI is the first medicinal product approved in the E.U. for treatment of patients with multiply relapsed or refractory aggressive NHL that addresses an unmet medical need," said
James A. Bianco, M.D., President and CEO of CTI. "Importantly, the IQWiG assessment has no current impact on a physician's ability to prescribe PIXUVRI for patients in
Germany. The reimbursement process in
Germany is designed to allow companies and external experts in treatment of the disease to have an opportunity to provide clarification on the benefits of the drug to G-BA during the hearing process. The G-BA will then make a final independent decision as to whether or not there is an additional benefit. We believe PIXUVRI offers patients suffering from aggressive NHL a safe and effective therapy, where there currently is no standard of care."
About PIXUVRI (pixantrone)
PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI 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 PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.