aggressive b cell lymphoma | Aggressive treatment of non-Hodgkin's lymphoma

Aggressive treatment of non-Hodgkin's lymphoma



Second Nice guidance project for the aggressive treatment of non-Hodgkin's lymphoma, Pixuvri ® (pixantrone)

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) announced that the National Institute for Excellence in Health and Care (Nice). A non-departmental public body of the Department of Health in the United Kingdom, has published second draft advice on the use of PIXUVRI (®) (Pixantrone) as a monotherapy for the treatment of adult patients with multiple relapses or Non-Hodgkin of refractory aggressive B lymphocyte lymphomas (patients with aggressive B-cell NHL that failed 2 or 3 previous therapy lines).

The draft evaluation Final Document (mania) does not recommend the funding of Pixantrone (PIXUVRI) by the National Health Service of the UK (NHS). The mania is open to appeal until July 11, 2013, and any incoming call will be considered by the independent Committee of Experts during the next stage of development of advice, according to the process presented by Nice.

In addition, CTI in coordination with the Nice Patient Access Plan Liaison Unit (PASLU) has entered into agreement with the Health UK Department on a patient access plan and applies for quick reestimation by Nice. These plans involve innovative evaluation agreements designed to improve profitability and to facilitate patient access to specific drugs or other technologies.

"Our intention is to continue working with nice to provide support for PIXUVRI because a major therapy we believe is a population of non-desservieset patients for PIXUVRI to represent the first approved pharmaceutical product Specifically for patients with aggressive B-cell NHL that have failed 2 or 3 previous lines of therapy, said James a. Bianco, M.D., President and CEO of CTI. The overall data from the PIX301 pivotal Phase 3 clinical test demonstrated a favorable benefit-to-risk ratio.

We believe the ongoing support among British lymphoma experts, data in the marked population of patients with aggressive B lymphocyte NHL that failed 2 or 3 previous therapy lines, and recent approval of a patient plan Access by the Department of Health in England and Wales demonstrates our commitment to bring this new therapy approved to patients with aggressive NHL in 3 line (RD) Recovery arrangement. "There are no other products licensed for use in 3 (RD) or 4th line," said Professor Finbarr E. Cotter, professor of hematology and chair of Experimental Hematology, Center for Haemato-Oncology, Barts Cancer Institute.

As a representative for the British Society for Hematology, I feel it is important for Nice to approve the pixantrone to make it available with clear advice for its indication authorized only by haemato-oncologists in England for the small number of unfortunate patients when the opportunity for potentially curative stem cell transplantation is always a possibility if a complete response is achieved.


In May 2012, the European Commission (EC) granted conditional sales authorisation in the European Union (EU) for PIXUVRI as a monotherapy for adult patients with multiply aggressive relapsed or refractory B lymphocyte NHL based on The results of the enlargement, or the PIX301, randomized clinical trial pivoting Phase 3. 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 receiving treatment. Prior to the approval of PIXUVRI to the EU, there was no approved agent or level of care in this disease. The PIX301 trial was designed using agents in the comparator arm that have anti-tumor activity in the relapsed disease and is typically used as a palliative therapy for these patients.


About Pixuvri (Pixantrone)
Pixuvri is a novel aza-anthracenedione with unique structural and physico-chemical properties. Unlike related compounds, Pixuvri forms stable DNA adducts and in preclinical models has higher anti-lymphoma activity than related compounds. Pixuvri is structurally designed so that it can not bind to iron and perpetuate the production of oxygen radicals or form a long-lived hydroxyl metabolite-both of which are putative mechanisms for a cardiotoxicity induced by a Acute and chronic anthracycline. These new pharmacological properties allow Pixuvri to be administered to patients with lifetime exposure near anthracyclines without the unacceptable rates of cardiotoxicity.

In May 2012, the European Commission (EC) granted the conditional marketing authorisation for Pixuvri as a monotherapy for the treatment of adult patients with relapse or aggressive NHL refractory multiplication.

The benefit of PIXUVRI treatment was not established in patients when used as a fifth line or superior to chemotherapy in patients who are refractory to the last therapy. The summary of product characteristics (RCP) has complete prescription information, including the safety and efficacy profile of PIXUVRI in the approved indication. CPR is available at www.pixuvri.eu.

CTI is currently accumulating patients in a Phase 3 trial comparing PIXUVRI and rituximab with Gemcitabine and rituximab as part of the NHL's aggressive B-cell. Pixuvri does not have the marketing authorization in the United States.



About non-Hodgkin's lymphoma
Non-Hodgkin's lymphoma is the sixth most common cancer in the UK, in 2010, 12 180 people were diagnosed with disease (1) NHL is caused by abnormal proliferation of lymphocytes, cells that are essential for the Functioning of the immune system.. It usually comes from the lymph nodes and spreads through the lymphatic system. NHL can be classified into two major forms-aggressive and indolent NHL. Aggressive NHL is an increasingly rapid form of disease that moves in an advanced stage much faster than the indolent NHL, which progresses more slowly.

There are many sub-types of NHL, but aggressive B-cell NHL is the most common and represents about 50 percent of NHL cases. (2) After initial aggressive NHL treatment with anthracycline-based combined therapy, one-third of patients generally develop disease progression (3). About half of these patients are likely to be eligible for a second-line intensive treatment and stem cell transplant, although 50 percent is supposed to not respond. (3) For patients who do not respond or relapse after the second line treatment, treatment options are limited and generally palliative only (3).


About Conditional Marketing Authorization
Similar to the accelerated approval regulation in the United States, conditional authorisations are granted in the EU to drugs with an assessment of the positive risk/benefit ratio that meet unmet medical needs and whose Availability would result in a significant benefit to public health.

A conditional marketing authorization is renewable annually. In accordance with the terms of the conditional marketing authorization for PIXUVRI, CTI will be required to conduct a post-market study to confirm the clinical benefit previously observed.

(EMA) The Commission of the European Medicines Agency for medicinal products for human use has accepted PIX306, a randomized Phase 3 clinical trial of the CTI, which compares Pixuvri-rituximab to Gemcitabine-rituximab in patients who have relapsed after One to three previous schematics for aggressive B? NHL cell and are not eligible for autologous stem cell transplantation. As a condition of approval, CTI agreed to dispose of the results of PIX306 clinical trials in June 2015.