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Application to broaden label for Arzerra to include 1st line CLL submitted to the EMA
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First application to modify label indication for Arzerra since approval
COPENHAGEN, Denmark I October 4, 2013 I GlaxoSmithKline plc (LSE/NYSE:GSK) and Genmab A/S (GEN.CO) announced today the submission of a variation to the Marketing Authorization to the European Medicines Agency (EMA) 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 submission is based primarily on results from an international, multi-center, randomized 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 have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
About Chronic Lymphocytic Leukemia CLL is the most common form of leukemia in adults. In Europe, the incidence rate is 4.92 per 100,000 or approximately 11,019 new cases each year1. 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 commercialization agreement between Genmab and GlaxoSmithKline.
About GlaxoSmithKline 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.
About 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(r)), was approved to treat chronic lymphocytic leukemia 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.
SOURCE: Genmab
Post Views: 57
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Application to broaden label for Arzerra to include 1st line CLL submitted to the EMA
-
First application to modify label indication for Arzerra since approval
COPENHAGEN, Denmark I October 4, 2013 I GlaxoSmithKline plc (LSE/NYSE:GSK) and Genmab A/S (GEN.CO) announced today the submission of a variation to the Marketing Authorization to the European Medicines Agency (EMA) 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 submission is based primarily on results from an international, multi-center, randomized 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 have been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
About Chronic Lymphocytic Leukemia CLL is the most common form of leukemia in adults. In Europe, the incidence rate is 4.92 per 100,000 or approximately 11,019 new cases each year1. 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 commercialization agreement between Genmab and GlaxoSmithKline.
About GlaxoSmithKline 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.
About 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(r)), was approved to treat chronic lymphocytic leukemia 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.
SOURCE: Genmab
Post Views: 57
