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GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer
Date:1/30/2009

n 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) Osterborg A, Kipps et al. Ofatumumab (HuMax-CD20), a Novel CD20 Monoclonal Antibody, Is An Active Treatment for Patients with CLL Refractory to Both Fludarabine and Alemtuzumab or Bulky Fludarabine-Refractory Disease: Results from the Planned Interim Analysis of An International Pivotal Trial. Abstract #328. Presented at the American Society of Hematology Annual Meeting 2008.

(6) Osterborg A, Kipps et al. Ofatumumab (HuMax-CD20), a Novel CD20 Monoclonal Antibody, Is An Active Treatment for Patients with CLL Refractory to Both Fludarabine and Alemtuzumab or Bulky Fludarabine-Refractory Disease: Results from the Planned Interim Analysis of an International Pivotal Trial. Oral Presentation of Abstract #328. Presented at the American Society of Hematology Annual Meeting 2008.

(7) Available at www.clinicaltrials.gov.

(8) National Cancer Institute. "Waldenstrom Macroglobulinemia: Questions and Answers." http://www.cancer.gov/cancertopics/factsheet/Sites-Types/WM. Accessed January 15, 2009.

(9) Hagenbeek A, Gadeberg O, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008;111:5486-5495.

(10) Teeling JL, Mackus, W,J., et al. The Biological Activity of Human CD20 Monoclonal Antibodies Is Linked to Unique Epitopes on CD20. J Immunol. 2006;177:362-371.

(11) Glennie MJ, French RR, et al. Mechanisms of killing by anti-CD20 monoclonal antibodies. Molecular Immunology. 2007;44(16):3823-3837.

(12) Shanafelt TD, Byrd JC, et al. Narrative review: initial man
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