Arzerra (ofatumumab) receives positive opinion for conditional approval in Europe for refractory chronic lymphocytic leukaemia
London UK - GlaxoSmithKline (GSK) and Genmab A/S announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerraä (ofatumumab) for the treatment of refractory chronic lymphocytic leukaemia (CLL).
The CHMP has recommended the conditional marketing authorisation of ofatumumab in the European Union for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab. Fludarabine and alemtuzumab are standard therapies currently used to treat CLL.1,2
Chronic lymphocytic leukaemia is a cancer of the blood and bone marrow. In patients with CLL who have not responded to treatment, or who have disease progression within six months to the latest treatment, the disease is termed refractory. Patients with refractory CLL have limited treatment options and poor outcomes with existing treatments.3 Less than 25% of these patients respond to existing treatments.4
About conditional marketing authorisation
A conditional marketing authorisation is granted to a medicinal product with a positive benefit/risk assessment that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. A conditional marketing authorisation is renewable annually. As part of the conditions of the conditional marketing authorisation for ofatumumab, GSK will be required to provide further data.
Ofatumumab is a novel human monoclonal antibody with a unique mode of action. It targets a unique part of the CD20 molecule encompassing an epitope in the small loop.5 The CD20 molecule is a key target in CLL therapy, because it is expressed in most B cell malignancies.6
About GlaxoSmithKline in Oncology
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s revolutionary ‘bench to bedside’ approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.
GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious disease. This innovative research is one way GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – can deliver on its commitment to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.
Genmab AS is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab’s world class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab’s products and technology visit www.genmab.com
Notes to editors:
Arzerra® is a registered trade mark of the GlaxoSmithKline group of companies in the US and the proposed trade name in Europe, Asia-Pacific, Japan and emerging countries.
1. Abbott BL. Chronic lymphocytic leukaemia: recent advances in diagnosis and treatment. Oncologist 2006;11(1): 21-30.
2. Robak T. Novel monoclonal antibodies for the treatment of chronic lymphocytic leukemia. Curr Cancer Drug Targets 2008; 8:156-171.
3. Keating MJ, Finn I, Jain V. et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood 2002; 99: 3554-3561.
4. Tam CS, O’Brien S, Lerner S. et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leukemia and Lymphoma. 2007; 48(10): 1931-1939.
5. Teeling JL, Mackus WJ, Wiegman LJ. et al. The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol 2006; 177: 362-71.
6. Cragg M S, Walshe CA, Ivanov AO. et al. The biology of CD20 and its potential as a target for mAb therapy. Curr Dir Autoimmun 2005; 8: 140-74.
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