February 27, 2014
Cell Therapeutics, Inc. today reported that the National Institute for Health and Care Excellence (NICE), the independent body responsible for driving improvement and excellence in the health and social care system in the UK, has published final guidance recommending prescription of PIXUVRI® (pixantrone) as a cost-effective monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL), which includes diffuse large B-cell lymphoma. CTI estimates that there are approximately 1,600 to 1,800 people in the UK diagnosed with multiply relapsed aggressive B-cell NHL per year.
“NICE’s final guidance on PIXUVRI means that physicians in England and Wales now have access to the only approved therapy for their patients with aggressive B-cell NHL in the third- and fourth-line salvage setting,” James A. Bianco, M.D., President and Chief Executive Officer of CTI. “We hope the NHS commissioners will recognize the lack of suitable treatment options that exist for patients at this stage of the disease and list PIXUVRI on hospital formularies as soon as possible.”
The final guidance determines PIXUVRI cost effective and recommends prescription of PIXUVRI as an option for certain people with histologically confirmed aggressive B-cell NHL, who have previously received rituximab and are receiving PIXUVRI as a third- or fourth-line treatment, for as long as CTI makes the Patient Access Scheme (PAS) available. The PAS is a confidential pricing and access agreement with the United Kingdom’s Department of Health.
Publication of the final guidance by NICE follows the final appraisal determination, or FAD, that was issued in January 2014. Now that the final guidance is published, the NHS is expected to implement it within 90 days. CTI expects to officially launch PIXUVRI in England and Wales this spring, after the FAD has been largely implemented. For more information on NICE’s final guidance, go to www.pixuvri.eu.
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.
In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available atwww.pixuvri.eu. PIXUVRI does not have marketing approval in the United States.
see the full release here.