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Pixuvri® launched in UK for adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma

Cell Therapeutics, Inc. has 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 ), 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)1,2 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.3,4

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.5

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.

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 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 at www.pixuvri.eu. PIXUVRI does not have marketing approval in the United States. ?

About NHL

NHL is the sixth most common cancer in the UK; in 2010, 12,180 people were diagnosed with the disease.6 NHL is caused by the abnormal proliferation of lymphocytes, cells that are key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms – aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.

There are many subtypes of NHL, but aggressive B-cell NHL is the most common and accounts for about 55 percent of NHL cases.1 After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease.7 Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50 percent are expected not to respond.7 For those patients who fail to respond or relapse following second line treatment, treatment options are limited, and usually palliative only.7

Source

1. Harris NL, et al. The World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues. Report of the Clinical Advisory Committee meeting, Airlie House, Virginia, November, 1997. Ann Oncol. 1999 Dec;10(12):1419-32.

2. European Cancer Observatory, Cancer Fact Sheets, 2008. Available at: http://eco.iarc.fr/EUCAN/. Last accessed April 2014.

3. Hagemeister FB. Treatment of relapsed aggressive lymphomas: regimens with and without high-dose therapy and stem cell rescue. Cancer Chemother Pharmacol. 2002 May;49 Suppl 1:S13-20. Epub 2002 Apr 12.

4. Cabanillas F. Pixantrone: a new agent for relapsed aggressive lymphomas. Lancet Oncol. 2012 Jul;13(7):654-6. doi: 10.1016/S1470-2045(12)70232-2. Epub 2012 May 30.

5. Pettengell R. et al. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470- 2045(12)70212-7. Epub 2012 May 30.

6. Cancer Research UK, Cancer incidence for common cancers. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/incidence/commoncancers Last accessed April ??2014.

7. Friedberg JW. Relapsed/refractory diffuse large B-cell lymphoma. Hematology Am Soc Hematol Educ Program. 2011;2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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