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April 10, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the National Institute for Health and Care Excellence (NICE), a non-departmental public body of the Department of Health in the
United Kingdom, issued draft guidance on PIXUVRI
® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL). The draft guidance does not recommend funding of pixantrone (PIXUVRI) by the UK's National Health Service (NHS) and requests that consultees, including CTI, healthcare professionals and members of the public, comment on the preliminary recommendations, which are available to view on the NICE website. The consultation will be open until
May 1, 2013, and any comments received will be fully considered by the independent committee of experts during the next stage of guidance development.
May 2012, the European Commission (EC) granted conditional marketing authorization in the European Union (E.U.) for PIXUVRI as a monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial. PIXUVRI was made available to patients in eight countries in the European Union in the fourth quarter of 2012, and some patients in other countries have already started to receive the treatment. Prior to the approval of PIXUVRI in the E.U., there were no approved agents or standard of care in this disease. The PIX301 trial was designed utilizing agents in the comparator arm that have anti-tumor activity in relapsed disease and are typically employed as palliative therapy for these patients.
"We look forward to working with NICE to bring PIXUVRI to what we believe is an unserved patient population for whom PIXUVRI represents the first pharmaceutical product approved for patients with aggressive B-cell NHL in the E.U. in over 25 years," said
James A. Bianco, M.D., President and CEO of CTI. "The overall data from the Phase 3 PIX301 clinical trial demonstrated a favorable benefit-to-risk ratio for a disease where there is a clear unmet medical need and we believe this was confirmed by the European Commission in
May 2012 with its decision to grant conditional marketing authorization in the E.U. for PIXUVRI. We believe strong support among UK lymphoma experts and the data in the labeled population of patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy demonstrates PIXUVRI is a cost-effective therapy for this end-of-life disease population."
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.