Regulatory update – GSK and Genmab announce submission to US regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)
Issued: Friday 18 October 2013, London UK
GlaxoSmithKline plc [LSE/NYSE: GSK] and Genmab A/S [OMX: GEN] announced today the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
The application is based primarily on results from an international, multi-centre, randomised Phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in more than 400 patients with previously untreated CLL. Headline results from this trial were announced in May, 2013 and the full study results are scheduled to be presented at the 2013 American Society of Hematology Annual Meeting in December.
About Chronic Lymphocytic Leukaemia
CLL is the most common form of leukaemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013.1 At present, no curative chemotherapy is available.
About Arzerra® (ofatumumab)
Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. For the approved indication, please visit: http://us.gsk.com/html/medicines/index.html for full US Prescribing Information and http://health.gsk.com/ for the EU Summary of Product Characteristics (SPC).
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops2. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GlaxoSmithKline.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/.
Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukaemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
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GSK Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012. |
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of the GlaxoSmithKline group of companies. |
References
[1] American Cancer Society, Estimated Number of New Cancer Cases and Deaths by Sex, US, 2013, http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-037124.pdf, accessed September 18, 2013.
2 Teeling et al, J Immunol 2006;177:362-371
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